EPIC¿ VALVE (AORTIC)
Report
- Report Number
- 2135147-2025-04037
- Event Type
- Injury
- Date Received
- July 24, 2025
- Date of Event
- June 1, 2025
- Report Date
- August 21, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LWR
- PMA / PMN Number
- P040021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AS REPORTED IN A RESEARCH ARTICLE, VALSALVA SINUS PERFORATION CAUSED BY COR-KNOT DURING TOTALLY ENDOSCOPIC MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT. 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.
THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3: EVENT DATE IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
THE ARTICLE, "VALSALVA SINUS PERFORATION CAUSED BY COR-KNOT DURING TOTALLY ENDOSCOPIC MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 75-YEAR-OLD FEMALE PATIENT WITH SJÖGREN¿S SYNDROME AND SYSTEMIC LUPUS ERYTHEMATOSUS (SLE). IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM EPIC VALVE WAS CHOSEN FOR IMPLANT FOR AORTIC VALVE REPLACEMENT. COR-KNOT WAS USED TO SECURE THE ANNULAR SUTURES, ORIENTING THE FASTENERS OUTWARD PER MANUFACTURER GUIDELINES TO AVOID LEAFLET IMPINGEMENT. HOWEVER, IMMEDIATELY FOLLOWING AORTIC CROSS-CLAMP REMOVAL, SIGNIFICANT OOZING WAS OBSERVED FROM THE ANTERIOR AORTIC ROOT, NECESSITATING EMERGENT CONVERSION TO FULL STERNOTOMY. HEMOSTASIS PROVED CHALLENGING UNDER BEATING-HEART CONDITIONS, REQUIRING REAPPLICATION OF THE CROSS-CLAMP AND THE HEART WAS ARRESTED. A 3MM PERFORATION OF THE VALSALVA SINUS NEAR THE RIGHT CORONARY CUSP WAS NOTED, ADJACENT TO THE COMMISSURE BETWEEN THE RIGHT AND LEFT CORONARY CUSPS. PERFORATION WAS REPAIRED WITH ONE MATTRESS SUTURE EACH. THE PATIENT¿S POSTOPERATIVE COURSE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED WITHOUT MAJOR COMPLICATIONS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS AKITOSHI YAMADA, KITA-HARIMA MEDICAL CENTER, 926-250 ICHIBA-CHO, ONO, HYOGO, JAPAN, WITH CORRESPONDING E-MAIL: [email protected]].
THE ARTICLE, "VALSALVA SINUS PERFORATION CAUSED BY COR-KNOT DURING TOTALLY ENDOSCOPIC MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 75-YEAR-OLD FEMALE PATIENT WITH SJÖGREN¿S SYNDROME AND SYSTEMIC LUPUS ERYTHEMATOSUS (SLE). IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM EPIC VALVE WAS CHOSEN FOR IMPLANT FOR AORTIC VALVE REPLACEMENT. COR-KNOT WAS USED TO SECURE THE ANNULAR SUTURES, ORIENTING THE FASTENERS OUTWARD PER MANUFACTURER GUIDELINES TO AVOID LEAFLET IMPINGEMENT. HOWEVER, IMMEDIATELY FOLLOWING AORTIC CROSS-CLAMP REMOVAL, SIGNIFICANT OOZING WAS OBSERVED FROM THE ANTERIOR AORTIC ROOT, NECESSITATING EMERGENT CONVERSION TO FULL STERNOTOMY. HEMOSTASIS PROVED CHALLENGING UNDER BEATING-HEART CONDITIONS, REQUIRING REAPPLICATION OF THE CROSS-CLAMP AND THE HEART WAS ARRESTED. A 3MM PERFORATION OF THE VALSALVA SINUS NEAR THE RIGHT CORONARY CUSP WAS NOTED, ADJACENT TO THE COMMISSURE BETWEEN THE RIGHT AND LEFT CORONARY CUSPS. PERFORATION WAS REPAIRED WITH ONE MATTRESS SUTURE EACH. THE PATIENT¿S POSTOPERATIVE COURSE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED WITHOUT MAJOR COMPLICATIONS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS AKITOSHI YAMADA, KITA-HARIMA MEDICAL CENTER, 926-250 ICHIBA-CHO, ONO, HYOGO, JAPAN, WITH CORRESPONDING E-MAIL: [email protected]].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1921056 | EPIC¿ VALVE (AORTIC) | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | ABBOTT MEDICAL | UNK EPIC STENTED PORCINE HV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention |