GORE-TEX® SUTURE
Report
- Report Number
- 3003910212-2024-01605
- Event Type
- Injury
- Date Received
- December 16, 2024
- Date of Event
- October 3, 2023
- Report Date
- January 23, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- GAW
- PMA / PMN Number
- P820083
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
REMOVING D1001 INVESTIGATION CONCLUSION CODE AND ADDING CONCLUSION CODE D15.
A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W.L. GORE INTERNAL CASE NUMBER. B3: DATE OF EVENT WAS REQUESTED, BUT NOT PROVIDED, THEREFORE THE DATE THE ARTICLE WAS AVAILABLE ON LINE (10-3-2023) WILL BE USED. H3: REVIEW OF THE MANUFACTURING RECORDS AND ENGINEERING EVALUATION COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED TO GORE. H6 - CODE 4111: ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED FROM THE COMPLAINANT, BUT NO RESPONSE WAS RECEIVED. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE-TEX® SUTURE, MISUSE OF THIS SUTURE, LIKE ANY OTHER SUTURE, CAN RESULT IN SEVERE INJURY OR DEATH TO THE PATIENT. AS WITH ANY SUTURE, CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE WITH SURGICAL INSTRUMENTS OR EXPOSING THE SUTURE TO SHARP EDGES. IN ORDER TO MINIMIZE NEEDLE DAMAGE, DO NOT DRIVE THE NEEDLE FROM THE CHANNEL WHERE THE SUTURE IS ATTACHED. NEEDLES ARE NOT INTENDED TO BE IMPLANTED. AT LEAST SEVEN, EQUALLY TENSIONED, FLAT SQUARE THROWS ARE REQUIRED TO PRODUCE A SECURE KNOT WHEN TYING GORE-TEX® SUTURE. ADDITIONAL THROWS MAY BE NECESSARY DEPENDING ON SURGICAL CIRCUMSTANCES. WHEN TYING KNOTS WITH THE GORE-TEX® SUTURE, TENSION SHOULD BE APPLIED BY PULLING EACH STRAND OF THE SUTURE IN OPPOSITE DIRECTIONS WITH EQUAL FORCE. AS THE KNOT IS TENSIONED, THE AIR IN THE SUTURE IS FORCED OUT. CARE SHOULD BE TAKEN TO AVOID USING A JERKING MOTION WHICH COULD BREAK THE SUTURE. UNEVEN TENSIONING OF A WELL-FORMED SQUARE KNOT MAY RESULT IN AN UNSECURE KNOT. WHEN THE GORE-TEX® SUTURE IS PROPERLY TENSIONED AND FORMED, STANDARD SURGICAL KNOTTING TECHNIQUES WILL PRODUCE A SECURE KNOT. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
ADDED CONCLUSION CODE TO H6: D1001.
AMY BROWN, ALI FATEHI HASSANABAD, WILLIAM D.T. KENT, COREY ADAMS (2023), MITRAL VALVE RE-REPAIR AFTER LATE RUPTURE OF EXPANDED POLYTETRAFLUOROETHYLENE NEOCHORDS, CJC OPEN, VOLUME 5, ISSUE 12, 2023, PAGES 947-949, ISSN 2589-790X. HTTPS://DOI.ORG/10.1016/J.CJCO.2023.10.002. (HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S2589790X23002895). SUMMARY: THE OBJECTIVE OF THIS STUDY WAS TO DESCRIBE A CASE OF LATE RUPTURE OF CV-5 EPTFE [EXPANDED POLYETRAFLUOROTHYLENE] NEOCHORDS WITH SUCCESSFUL RE-REPAIR. A 60-YEAR-OLD MAN WAS ADMITTED TO THE HOSPITAL WITH HEART FAILURE FOLLOWING 2-WEEKS OF PROGRESSIVE DYSPNEA. EIGHT YEARS PRIOR, HE HAD UNDERGONE MITRAL VALVE REPAIR FOR PROLAPSED P2 SEGMENT USING CV-5 EPTFE GORE-TEX (W.L. GORE & ASSOCIATES INC, NEWARK, DE) NEOCHORDS AND A 30-MM PHYSIO II (EDWARDS LIFESCIENCES, IRVINE, CA) ANNULOPLASTY RING AND SINCE HAD BEEN CLINICALLY WELL. EIGHT MONTHS BEFORE ADMISSION, A ROUTINE FOLLOW-UP TRANSTHORACIC ECHOCARDIOGRAM SHOWED NORMAL BIVENTRICULAR FUNCTION WITH MODERATE MITRAL REGURGITATION (MR). ON ADMISSION, ECHOCARDIOGRAPHY SHOWED NORMAL BIVENTRICULAR FUNCTION WITH SEVERE ANTERIORLY DIRECTED MR CAUSED BY RECURRENT PROLAPSE OF THE POSTERIOR LEAFLET. GIVEN HIS ACUTE CHANGE IN SYMPTOMS AND IMAGING FINDINGS, HE WAS CONSENTED FOR A REDO MITRAL VALVE OPERATION. THE 4 GORE-TEX NEOCHORDS THAT HAD BEEN INSERTED ON TO THE FREE MARGIN OF THE LATERAL, AND MEDIAL ASPECT OF P2 HAD RUPTURED MIDWAY BETWEEN THE LEAFLET AND PAPILLARY MUSCLES. NEOCHORD INSERTIONS AT THE LEAFLET AND THE PAPILLARY MUSCLES WERE INTACT AND REMOVED BEFORE RE-REPAIR. THE NEOCHORD RUPTURE WAS SUSPECTED TO BE CAUSED BY SUTURE CALCIFICATION AND WEAKENING, BASED ON GROSS INSPECTION OF THE EXPLANTED NEOCHORDS. AN ADDITIONAL FACTOR THAT MAY HAVE CONTRIBUTED TO NEOCHORD WEAKENING IN THIS CASE WAS A PREVIOUS MOTOR VEHICLE ACCIDENT WITHIN APPROXIMATELY 1 YEAR OF HIS PRESENTATION. THE PREVIOUS ANNULOPLASTY RING WAS LEFT IN SITU AND WORKING THROUGH THE RING, THE VALVE WAS RE-REPAIRED USING 6 CV-4 EPTFE NEOCHORDS, SUTURED FROM THE FREE EDGE OF P2 TO THE MEDIAL AND LATERAL PAPILLARY MUSCLE HEADS. RESIDUAL CLEFTS BETWEEN P1 AND P2, AND P2 AND P3 WERE SUTURED CLOSED. POST-CARDIOPULMONARY BYPASS TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED TRIVIAL-TO-MILD RESIDUAL MR. RESULTS: THE PATIENT¿S POSTOPERATIVE COURSE WAS UNCOMPLICATED. WITH ATRIAL FIBRILLATION DELAYING HIS DISCHARGE, THE PATIENT WENT HOME FROM HOSPITAL ON POST-OPERATIVE DAY 8. FOLLOW-UP ECHOCARDIOGRAPHY 1.5 YEARS AFTER REOPERATION SHOWED NORMAL BIVENTRICULAR FUNCTION WITH TRIVIAL MR. CONCLUSION: ALTHOUGH RARE, EPTFE NEOCHORD RUPTURE HAS SIGNIFICANT CONSEQUENCES AND EMPHASIZES THE NECESSITY TO CONTINUE LONG-TERM FOLLOW-UP WITH ECHOCARDIOGRAPHIC SURVEILLANCE OF POSTOPERATIVE PATIENTS TO DETECT POSSIBLE LATE COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2377584 | GORE-TEX® SUTURE | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Other| R |