SJM TISSUE HEART VALVE (UNKNOWN)
Report
- Report Number
- 3005334138-2022-00127
- Event Type
- Death
- Date Received
- February 23, 2022
- Report Date
- February 23, 2022
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AS REPORTED IN A RESEARCH ARTICLE, TWO PATIENTS WITH PORCINE VALVES DIED POSTOPERATIVE. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE FOR A BIOCOR VALVE ARTEN100121084 REVISION C "PRECAUTIONS:¿ THE SAFETY AND EFFECTIVENESS OF THE BIOCOR¿ AND BIOCOR¿ SUPRA VALVES HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING SPECIFIC POPULATIONS... PATIENTS REQUIRING PULMONIC OR TRICUSPID VALVE REPLACEMENT" PLEASE NOTE, PER THE INSTRUCTIONS FOR USE FOR A EPIC VALVE ARTEN600214077 REVISION A "PRECAUTIONS:¿ THE SAFETY AND EFFECTIVENESS OF THE EPIC¿ AND EPIC¿ SUPRA VALVES HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING SPECIFIC POPULATIONS... PATIENTS REQUIRING PULMONIC OR TRICUSPID VALVE REPLACEMENT".
AS REPORTED IN A RESEARCH ARTICLE, TWO PATIENTS WITH PORCINE VALVES DIED POSTOPERATIVE. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE FOR A BIOCOR VALVE ARTEN100121084 REVISION C "PRECAUTIONS: THE SAFETY AND EFFECTIVENESS OF THE BIOCOR¿ AND BIOCOR¿ SUPRA VALVES HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING SPECIFIC POPULATIONS... PATIENTS REQUIRING PULMONIC OR TRICUSPID VALVE REPLACEMENT" PLEASE NOTE, PER THE INSTRUCTIONS FOR USE FOR A EPIC VALVE ARTEN600214077 REVISION A "PRECAUTIONS: THE SAFETY AND EFFECTIVENESS OF THE EPIC¿ AND EPIC¿ SUPRA VALVES HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING SPECIFIC POPULATIONS... PATIENTS REQUIRING PULMONIC OR TRICUSPID VALVE REPLACEMENT".
RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2022-00126, 3005334138-2022-00119 . THE ARTICLE, "BIOPROSTHETIC PULMONARY VALVE DYSFUNCTION IN CONGENITAL HEART DISEASE", WAS REVIEWED. THIS ARTICLE IS A RETROSPECTIVE SINGLE STUDY EXPERIENCE THAT AIMS TO IDENTIFY THE INCIDENCE AND TIMING OF DYSFUNCTION AND FAILURE OF STENTED BIOPROSTHETIC VALVES IN THE PULMONARY POSITION IN CONGENITAL HEART DISEASE PATIENTS. PERIMOUNT MAGNA, MAGNAEASE (EDWARDS LIFE SCIENCES) , TRIFECTA, BIOCOR, EPIC AORTIC, SUPRA AORTIC AND MITRAL VALVES (ABBOTT) AND MOSAIC, MOSAIC ULTRA, MOSAIC ULTRA CINCH VALVES (MEDTRONIC) WERE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED PORCINE STENTED AND BOVINE PERICARDIAL STENTED VALVES CAN BE IMPLANTED IN THE PULMONARY POSITION IN ALL AGE GROUPS SAFELY. HOWEVER, DESPITE SIMILAR RATES OF VALVE FAILURE, BOVINE PERICARDIAL STENTED VALVES HAVE A HIGHER INCIDENCE OF VALVE DYSFUNCTION AT MID-TERM FOLLOW-UP. [THE PRIMARY AND CORRESPONDING AUTHOR OF THIS ARTICLE IS PARTH M. PATEL MD, DIVISION OF CARDIOTHORACIC SURGERY, (B)(6).
RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2022-00126, 3005334138-2022-00119 . THE ARTICLE, "BIOPROSTHETIC PULMONARY VALVE DYSFUNCTION IN CONGENITAL HEART DISEASE", WAS REVIEWED. THIS ARTICLE IS A RETROSPECTIVE SINGLE STUDY EXPERIENCE THAT AIMS TO IDENTIFY THE INCIDENCE AND TIMING OF DYSFUNCTION AND FAILURE OF STENTED BIOPROSTHETIC VALVES IN THE PULMONARY POSITION IN CONGENITAL HEART DISEASE PATIENTS. PERIMOUNT MAGNA, MAGNAEASE (EDWARDS LIFE SCIENCES) , TRIFECTA, BIOCOR, EPIC AORTIC, SUPRA AORTIC AND MITRAL VALVES (ABBOTT) AND MOSAIC, MOSAIC ULTRA, MOSAIC ULTRA CINCH VALVES (MEDTRONIC) WERE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED PORCINE STENTED AND BOVINE PERICARDIAL STENTED VALVES CAN BE IMPLANTED IN THE PULMONARY POSITION IN ALL AGE GROUPS SAFELY. HOWEVER, DESPITE SIMILAR RATES OF VALVE FAILURE, BOVINE PERICARDIAL STENTED VALVES HAVE A HIGHER INCIDENCE OF VALVE DYSFUNCTION AT MID-TERM FOLLOW-UP. [THE PRIMARY AND CORRESPONDING AUTHOR OF THIS ARTICLE IS PARTH M. PATEL MD, DIVISION OF CARDIOTHORACIC SURGERY, (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2099314 | SJM TISSUE HEART VALVE (UNKNOWN) | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | ABBOTT MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Male | Death |