CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
Report
- Report Number
- 2015691-2021-06539
- Event Type
- Injury
- Date Received
- November 24, 2021
- Date of Event
- November 2, 2021
- Report Date
- January 3, 2022
- Manufacturer
- EDWARD LIFESCIENCES LLC
- Product Code
- DYE
- UDI-DI
- 00690103176148
- PMA / PMN Number
- P860057
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL MANUFACTURER NARRATIVE: THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.
H10: ADDITIONAL NARRATIVES. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.
H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS B5, B7, D4 (EXPIRATION DATE), H4, H6 (DEVICE CODE, TYPE OF INVESTIGATION).
ADDITIONAL MANUFACTURER NARRATIVE: THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.
THROUGH THE IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE IMPLANTED FOR 5 YEARS, 9 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA ON EXERTION AND FATIGUE. THE DEVICE WAS REPLACED WITH A 23MM 9750TFX TRANSCATHETER VALVE SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY COMPLICATIONS AND WAS TRANSFERRED TO THE PACU. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
THROUGH THE IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE IMPLANTED FOR 5 YEARS, 9 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO SEVERELY THICKENED LEAFLETS AND SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA ON EXERTION AND FATIGUE. THE DEVICE WAS REPLACED WITH A 23MM 9750TFX TRANSCATHETER VALVE SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY COMPLICATIONS AND WAS TRANSFERRED TO THE PACU.
THROUGH THE IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE IMPLANTED FOR 5 YEARS, 9 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA ON EXERTION AND FATIGUE. THE DEVICE WAS REPLACED WITH A 23MM (B)(4) TRANSCATHETER VALVE SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY COMPLICATIONS AND WAS TRANSFERRED TO THE PACU. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1768902 | CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART-VALVE | DYE | EDWARD LIFESCIENCES LLC | 3300TFX | NA | 00690103176148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | Hospitalization| R| L |