FDA Adverse Event Injury Summary report: N

SEE H10.

MDR report key: 17758644 · Received September 15, 2023

Report

Report Number: 2015691-2023-15983
Event Type: Injury
Date Received: September 15, 2023
Report Date: October 23, 2023
Manufacturer: EDWARDS LIFESCIENCES
Product Code: DYE
PMA / PMN Number: SEE H10.
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER, PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative · 0

THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION IS IN PROCESS. D1./D4./G5. THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/S001. 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 EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Description of Event or Problem · 0

EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH A 23MM 2900 VALVE WAS DIAGNOSED AS AORTIC STENOSIS AND MODERATE AORTIC REGURGITATION SECONDARY TO STRUCTURAL VALVE DETERIORATION AFTER IMPLANT DURATION OF UNKNOWN PERIOD. THE PATIENT PRESENTED WITH A SYMPTOM OF DYSPNEA ON EXERTION. VALVE-IN-VALVE PROCEDURE WITH SAPIEN TRANSCATHETER VALVE IS UNDER CONSIDERATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1268825	SEE H10.	REPLACEMENT HEART-VALVE	DYE	EDWARDS LIFESCIENCES	SEE. H10.	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR	Male	Other\| L