CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
Report
- Report Number
- 2015691-2021-07033
- Event Type
- Injury
- Date Received
- December 23, 2021
- Date of Event
- December 8, 2021
- Report Date
- March 9, 2022
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- P860057/S04
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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
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 MANUFACTURER NARRATIVE: H3: EVALUATION SUMMARY: CUSTOMER REPORT OF CONTAMINATION WAS CONFIRMED. VALVE WAS RETURNED STILL ATTACHED TO VALVE HOLDER WITH ALL THREE GREEN SUTURES INTACT AT THE CUTTING CHANNELS. A FIBER-LIKE PARTICULATE APPROXIMATELY 6MM LONG WAS FOUND ON THE INFLOW SURFACE OF LEAFLET 3. THE FIBER WAS NOT ABLE TO BE RINSED OFF DURING RINSE PROCEDURE PER IFU. ONE END OF THE PARTICULATE APPEARED TO BE A HAIR FOLLICLE AND THE OTHER END OF THE PARTICULATE WAS TAPERED. PHOTOS PROVIDED APPEARED CONSISTENT WITH FINDINGS.
EDWARDS RECEIVED NOTIFICATION THAT THIS VALVE MODEL 3300TFX25MM WAS NOT USED DUE TO CONTAMINATION. AS REPORTED FOREIGN MATERIALS (LIKELY TO BE HAIR) WERE OBSERVED ON TWO VALVE LEAFLETS. THE ISSUE WAS OBSERVED AFTER THE VALVE WAS OPENED AND SCREWED ONTO THE HANDLE. REPORTEDLY, THE OPERATOR WASHED THE VALVE AND NOTICED THE FOREIGN MATERIAL. THE NURSE WASHED THE VALVE WITH SALINE AND ONE PARTICULATE CAME OFF BUT THE OTHER PARTICULATE WAS NOT REMOVED, SO IT WAS DECIDED TO NOT USE THE VALVE. THERE WAS NO INJURY FOR THE PATIENT. THE DEVICE WAS NOTED AS TO BE RETURNED FOR EVALUATION
EDWARDS RECEIVED NOTIFICATION THAT THIS VALVE MODEL 3300TFX25MM WAS NOT USED DUE TO CONTAMINATION. AS REPORTED FOREIGN MATERIALS (LIKELY TO BE HAIR) WERE OBSERVED ON TWO VALVE LEAFLETS. THE ISSUE WAS OBSERVED AFTER THE VALVE WAS OPENED AND SCREWED ONTO THE HANDLE. REPORTEDLY, THE OPERATOR WASHED THE VALVE AND NOTICED THE FOREIGN MATERIAL. THE NURSE WASHED THE VALVE WITH SALINE AND ONE PARTICULATE CAME OFF BUT THE OTHER PARTICULATE WAS NOT REMOVED, SO IT WAS DECIDED TO NOT USE THE VALVE. THERE WAS NO INJURY FOR THE PATIENT. PICTURES WERE ATTACHED TO THIS FILE. THE DEVICE WAS NOTED AS TO BE RETURNED FOR EVALUATION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1979617 | CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART-VALVE | DYE | EDWARDS LIFESCIENCES | 3300TFX25MM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |