ACURATE neo2 and ACURATE Prime
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| ACURATE Prime Aortic Valve | All lots. | H74939690250 H74939690270 H74939690230 H74939690290 |
| ACURATE Neo2 Loading Kit | All lots. | SYM-AC-010 |
| ACURATE Prime Delivery System | All lots. | H749396822729 H749396822325 |
| ACURATE Neo2 Transfemoral Delivery System | All lots. | SYM-DS-005 SYM-DS-010 |
| ACURATE Prime Loading Kit | All lots. | H749396942729 H749396942325 |
| ACURATE Neo2 Valve | All lots. | SYM-SV27-004 SYM-SV23-004 SYM-SV25-004 |
| ACURATE Prime XL Delivery System | All lots. | SYM-DS-009-C |
| ACURATE Prime XL Loading Kit | All lots. | SYM-AC-009-C |
| ACURATE Prime XL Aortic Valve | All lots. | SYM-SV29-009-C |
Issue
Boston Scientific has become aware of new information related to valve underexpansion, that emerged from review of the 1-year clinical trial data from the ACURATE IDE.
Detailed investigation of the 1-year data identified valve underexpansion as a potential leading contributing factor of the missed primary endpoint (ACURATE neo2 non- inferiority to the Control group for the composite of death, stroke and rehospitalisation). ACURATE neo2 valve underexpansion was associated with an increased rate of primary endpoint events compared to cases where the ACURATE neo2 valve was well expanded. However, valve underexpansion was not previously identified through clinical experiences with the ACURATE neo2 valve nor through ACURATE neo2 post market surveillance.
The Instructions for Use (IFU) have been updated to include the risk of valve underexpansion and the practices that may reduce this risk.
Recall start date: November 7, 2024
Additional information
Details
| Boston Scientific Corporation |
| 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752 |
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