GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
Report
- Report Number
- 3007284313-2022-02093
- Event Type
- Malfunction
- Date Received
- August 31, 2022
- Date of Event
- August 3, 2022
- Report Date
- November 1, 2022
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- UDI-DI
- 00733132651054
- PMA / PMN Number
- P200030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE FOLLOWING PATIENT MEDICAL INFORMATION WAS PROVIDED: MEDICATIONS: ALBUTEROL HFA 90 MCG/ACTUATION INHALATION INHALER, AMLODIPINE (NORVASC) 10 MG ORAL TABLET, ASPIRIN, ENTERIC COATED, (ECOTRIN) 81 MG ORAL TABLET, ATORVASTATIN (LIPITOR) 40 MG ORAL TABLET, FAMOTIDINE (PEPCID) 20 MG ORAL TABLET, HYDROCODONE-ACETAMINOPHEN (LORCET,LORTAB,NORCO) 5-325 MG ORAL TABLET, IBUPROFEN (MOTRIN) 200 MG ORAL TABLET, LISINOPRIL (PRINIVIL, ZESTRIL) 40 MG ORAL TABLET, METOPROLOL SUCCINATE, 24-HOUR, (TOPROL XL) 100 MG ORAL TABLET, NAPROXEN SODIUM (ALEVE) 220 MG ORAL TABLET, SENNOSIDES-DOCUSATE SODIUM (SENOKOT-S) 8.6-50 MG ORAL TABLET. MEDICAL AND SURGICAL HISTORY: ALCOHOL DEPENDENCE, CIGARETTE SMOKER, CLOSED RIGHT HIP FRACTURE, FALL DOWN STAIRS ON (B)(6) 2018), L/T RT FEMORAL FX. FRACTUR ON (B)(6) 2018), RT FOOT (2003). RT FEMORAL FX 2/2 FALL WHILE DRINKING ON (B)(6) 208)., TRAUMATIC AMPUTATION OF TIP OF FINGER OF LEFT HAND (1985), LEFT 2,3RD FINGERTIPS REATTACHED, ULCER ON (B)(6) 2018), BLEEDING ULCER APPROX 20 YR AGO, EVASC RPR DPLMNT AORTO-AORTIC NDGFT - ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR, TOTAL HIP REPLACEMENT. (B)(4). 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.
H6: CODE C19, NO DEVICE PROBLEM FOUND: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D15, CAUSE NOT ESTABLISHED: IMAGING AND ENGINEERING REVIEWS WERE CONDUCTED BUT A DEFINITIVE CAUSE WAS NOT ABLE TO BE ESTABLISHED AS A RESULT OF THESE INVESTIGATIONS. SUMMARIES OF IMAGING AND ENGINEERING EVALUATIONS ARE INDICATED BELOW. IMAGING EVALUATION SUMMARY: IMAGES RECEIVED VIA EMAIL WITH NO PATIENT IDENTIFIER OR DATE OF ACQUISITION IN IMAGE. UNABLE TO CONFIRM LEADING END OF ENDOPROSTHESIS UNABLE TO BE FULLY REOPENED WITH AVAILABLE IMAGE SET. UNABLE TO CONFIRM TYPE IA ENDOLEAK. ENGINEERING EVALUATION SUMMARY: THE DEVICE EVALUATION PERFORMED BY ENGINEERING SHOWED THE FOLLOWING: THE CXT281412 EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS LOT/SERIAL 24719849 WAS NOT RETURNED FOR ANALYSIS. IMAGES WERE PROVIDED FOR CONSIDERATION; HOWEVER, THE DIGITAL ITEMS DID NOT MEET THE DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) STANDARD. THEREFORE, THE IMAGING EVALUATION LIMITED, AND NO CONFIRMATIONS WERE MADE BY THE IMAGING TEAM. BASED ON THE FINDINGS FROM THE EVALUATION, THE STATEMENTS FROM THE EVENT DESCRIPTION THAT ¿ONE SIDE OF THE LEADING END OF THE DEVICE WAS BENT OVER¿ AND ¿THE DEVICE WOULD NOT OPEN UP AND REMAINED PARTIALLY BENT AT THE LEADING EDGE¿ COULD NOT BE CONFIRMED. ADDITIONALLY, THE REPORTED PRESENCE OF A ¿TYPE IA ENDOLEAK¿ COULD NOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. THE ROOT CAUSE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION AND NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED DURING THE INVESTIGATION. AS A RESULT, A CAPA REQUEST IS NOT REQUIRED PER MD145952 (REVISION 24), ENGINEERING EVALUATION TASK PROCEDURE. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED PER MD24024, PROCEDURE FOR EVENT TRENDING, ANALYSIS, AND REVIEW. 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. G3/G4 DATE RECEIVED BY MANUFACTURER UPDATED TO 17-OCT-2022 AS EVALUATION ACTIVITIES WERE COMPLETED IN FULL ON THIS DATE.
REPLACED ANNEX G/COMPONENT CODE. CORRECTED FROM, "STENT" TO "DEVICE DEPLOYER".
ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR ENDOVASCULAR REPAIR OF AN ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. AS REPORTED, DURING DEPLOYMENT THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WAS LANDED SLIGHTLY HIGH WITHIN THE PATIENT ANATOMY AND NEEDED TO BE REPOSITIONED. AS REPORTED, THE DEVICE WAS RE-CONSTRAINED AND THE CATHETER PULLED DISTALLY TO REPOSITION THE DEVICE. AS REPORTED, ONE SIDE OF THE LEADING END OF THE DEVICE WAS BENT OVER. AS REPORTED, AN ATTEMPT WAS MADE TO FULLY RECONSTRAIN THE ENDOPROSTHESIS AGAIN AND TO REPOSITION IT, BUT THIS DID NOT WORK AND THE DEVICE WOULD NOT OPEN UP AND REMAINED PARTIALLY BENT AT THE LEADING EDGE. AS REPORTED, THERE WAS A TYPE IA ENDOLEAK PRESENT. REPORTEDLY, THE LEADING END OF THE ENDOPROSTHESIS WAS BALLOONED AND IT WAS CORRECTED. THE PATIENT TOLERATED THE PROCEDURE. AS REPORTED THE PATIENT¿S AORTIC NECK WAS STRAIGHT WITH SOME THROMBUS. THE FIELD SALES ASSOCIATED COMMENTED THAT IT APPEARED THAT THE OLIVE TIP HAD CAUGHT THE FIRST SET OF STENT STRUTS OR CONSTRAINING LOOP. IMAGES WERE PROVIDED FOR CONSIDERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2069489 | GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. | CXT281412 | 00733132651054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Other | SEE H10/H11 |