EPIC¿ VALVE (MITRAL)
Report
- Report Number
- 2135147-2024-01668
- Event Type
- Injury
- Date Received
- April 12, 2024
- Date of Event
- March 15, 2024
- Report Date
- May 22, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LWR
- PMA / PMN Number
- P040021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE ATTACHMENT: TRANSCATHETER MITRAL VALVE-IN-VALVE EXPLANT: LESSONS LEARNED.
SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF EPIC VALVE WAS REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH VON WILLEBRAND DISEASE. SOME OF THE COMPLICATIONS REPORTED WERE SURGICAL INTERVENTION (VALVE-IN-VALVE, SURGICAL EXPLANT), HOSPITALIZATION, MITRAL REGURGITATION, DYSPNEA AND MITRAL STENOSIS. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS.
THE ARTICLE, "TRANSCATHETER MITRAL VALVE-IN-VALVE EXPLANT: LESSONS LEARNED", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 66-YEAR-OLD MALE PATIENT WITH VON WILLEBRAND DISEASE. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 29MM EPIC VALVE WAS IMPLANTED. IT WAS THEN REPORTED 10 YEARS POST-PROCEDURE ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH DYSPNEA DUE TO SEVERE MITRAL REGURGITATION. A DECISION WAS MADE TO PERFORM A TRANSCATHETER VALVE-IN-VALVE PROCEDURE WITH A 26MM SAPIEN VALVE. IT WAS THEN REPORTED ONE YEAR POST-INTERVENTION, THE PATIENT HAD ELEVATED GRADIENT. A DECISION WAS MADE TO SURGICALLY REMOVE BOTH 29MM EPIC VALVE WITH THE EMBEDDED 26MM SAPIEN VALVE. A 27/29 ON-X MECHANICAL VALVE WAS THEN IMPLANTED WITH NO ADVERSE PATIENT CONSEQUENCES. THE ARTICLE CONCLUDED THAT MITRAL VALVE-IN-VALVE EXPLANT IS TECHNICALLY FEASIBLE. THE AUTHORS RECOMMENDED EN BLOC REMOVAL OF BOTH VALVES AS THE SAFEST METHOD OF VALVE EXPLANT. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MOHAMMAD BASHIR, UNIVERSITY OF IOWA CARVER COLLEGE OF MEDICINE, DEPARTMENT OF CARDIOTHORACIC SURGERY, IOWA CITY, IOWA 52242, WITH CORRESPONDING EMAIL: [email protected]]
THE ARTICLE, "TRANSCATHETER MITRAL VALVE-IN-VALVE EXPLANT: LESSONS LEARNED", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 66-YEAR-OLD MALE PATIENT WITH VON WILLEBRAND DISEASE. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 29MM EPIC VALVE WAS IMPLANTED. IT WAS THEN REPORTED 10 YEARS POST-PROCEDURE ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH DYSPNEA DUE TO SEVERE MITRAL REGURGITATION. A DECISION WAS MADE TO PERFORM A TRANSCATHETER VALVE-IN-VALVE PROCEDURE WITH A 26MM SAPIEN VALVE. IT WAS THEN REPORTED ONE YEAR POST-INTERVENTION, THE PATIENT HAD ELEVATED GRADIENT. A DECISION WAS MADE TO SURGICALLY REMOVE BOTH 29MM EPIC VALVE WITH THE EMBEDDED 26MM SAPIEN VALVE. A 27/29 ON-X MECHANICAL VALVE WAS THEN IMPLANTED WITH NO ADVERSE PATIENT CONSEQUENCES. THE ARTICLE CONCLUDED THAT MITRAL VALVE-IN-VALVE EXPLANT IS TECHNICALLY FEASIBLE. THE AUTHORS RECOMMENDED EN BLOC REMOVAL OF BOTH VALVES AS THE SAFEST METHOD OF VALVE EXPLANT. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MOHAMMAD BASHIR, UNIVERSITY OF IOWA CARVER COLLEGE OF MEDICINE, DEPARTMENT OF CARDIOTHORACIC SURGERY, IOWA CITY, IOWA 52242, WITH CORRESPONDING EMAIL: [email protected]].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1509959 | EPIC¿ VALVE (MITRAL) | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | ABBOTT MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Required Intervention| H |