GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
Report
- Report Number
- 2017233-2025-05789
- Event Type
- Malfunction
- Date Received
- February 3, 2025
- Date of Event
- January 14, 2025
- Report Date
- March 18, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- PRL
- PMA / PMN Number
- P160021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. 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.
UPDATED CODES BASED ON INVESTIGATION FINDINGS. B19 -INCOMPLETE DEVICE RETURNED; DELIVERY CATHETER WAS RETURNED. STENT-GRAFT REMAINS IMPLANTED. A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. ENGINEERING EVALUATION: THE DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM THROUGH THE SHEATH, COULD NOT BE CONFIRMED DURING ENGINEERING EVALUATION BECAUSE OF DIFFERENCES BETWEEN CONDITIONS SEEN IN VIVO AND THOSE SEEN IN THE LABORATORY; IT WAS ALSO UNABLE TO BE CONFIRMED DURING IMAGING EVALUATION OF THE AVAILABLE CLINICAL ITEM. AS REPORTED, DURING WITHDRAWAL OF THE DELIVERY CATHETER IT BECAME STUCK; REPEATED ATTEMPTS TO WITHDRAW WERE UNSUCCESSFUL. THE DAMAGE OBSERVED ON THE RETURNED DEVICE IS CONSISTENT WITH THE REPORTED WITHDRAWAL DIFFICULTY; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE BROKEN CATHETER SHAFT AND BROKEN COMPONENTS, WERE CONFIRMED DURING ENGINEERING EVALUATION; WHETHER THE TIP OF THE BALLOON BROKE OFF AND REMAINS IN THE PATIENT COULD NOT BE CONFIRMED DURING IMAGING EVALUATION OF THE AVAILABLE CLINICAL ITEM. AS REPORTED, FOLLOWING REPEATED UNSUCCESSFUL ATTEMPTS TO WITHDRAW THE CATHETER, THE DECISION WAS MADE TO PULL BACK ON THE CATHETER; THIS RESULTED IN THE TIP OF THE BALLOON BREAKING OFF INSIDE THE PATIENT, ALONG WITH THE INFLATION HUB OF THE CATHETER DETACHING OUTSIDE OF THE PATIENT. ENGINEERING EVALUATION OF THE RETURNED DEVICE OBSERVED A MATERIAL FAILURE AS WELL AS DEFORMATION/NECKING OF THE CATHETER; THESE OBSERVATIONS ARE CONSISTENT WITH EXCESSIVE FORCE APPLIED DURING WITHDRAWAL. PER THE DEVICE INSTRUCTIONS FOR USE (IFU), EXCESSIVE OR ABRUPT FORCE DURING CATHETER REMOVAL MAY DAMAGE THE DELIVERY CATHETER OR INTRODUCER SHEATH. THEREFORE, THE ROOT CAUSE OF THESE ADDITIONAL REPORTED FAILURE MODES CAN BE ATTRIBUTED TO THE REASONABLY FORESEEABLE MISUSE OF THE USER APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE INSTRUCTIONS FOR USE (IFU), FOR THE APPROPRIATE REGION AND TIME-PERIOD, WAS REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL. THE IFU INCLUDES THE FOLLOWING: ¿FORCEFULLY REMOVING THE DELIVERY SYSTEM AFTER DEPLOYMENT MAY CAUSE THE ENDOPROSTHESIS TO MIGRATE, AND/OR CAUSE INACCURATE PLACEMENT OR DELIVERY SYSTEM DAMAGE WHICH MAY REQUIRE ADDITIONAL ENDOVASCULAR PROCEDURES OR SURGICAL INTERVENTION¿IF RESISTANCE IS ENCOUNTERED UPON ATTEMPTED REMOVAL, DO NOT FORCE REMOVAL, USE FLUOROSCOPY AND CONVENTIONAL TECHNIQUES TO DETERMINE AND REMEDY THE CAUSE OF RESISTANCE BEFORE PROCEEDING¿EXCESSIVE OR ABRUPT FORCE DURING CATHETER REMOVAL MAY DAMAGE THE DELIVERY CATHETER OR INTRODUCER SHEATH.¿
ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND AN 8L MM X 59 MM REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) IN THE RIGHT INTERNAL ILIAC ARTERY (IIA). IT WAS REPORTED THE PHYSICIAN WAS ABLE TO ADVANCE THE VBX DEVICE DELIVERY SYSTEM CATHETER IPSILATERALLY USING AN 10F GORE® DRYSEAL FLEX INTRODUCER SHEATH, OVER 0.035" GLIDEWIRE ADVANTAGE GUIDE WIRE. REPORTEDLY, RESISTANCE WAS MET, AND IT WAS DIFFICULT TO TRACK THE DELIVERY CATHETER TO THE TARGET TREATMENT SITE. IT WAS REPORTED THE EXTREME ANGULATION AND TORTUOUS ANATOMY OF THE VESSEL, AND THE PREVIOUSLY PLACE IBE DEVICE WERE SUSPECTED TO BE THE CAUSE OF THE RESISTANCE. REPORTEDLY, THE DEVICE WAS BEYOND THE CONFINES OF THE SHEATH AND THEREFORE IT IS NOT SUSPECTED THE SHEATH WAS RESPONSIBLE FOR THE RESISTANCE. REPORTEDLY, THE DELIVERY CATHETER COULD NOT BE ADVANCED TO THE TARGET TREATMENT SITE, THE DECISION WAS MADE TO DEPLOY THE ENDOPROSTHESIS IN PLACE. IT WAS REPORTED NO MAJOR BRANCH VESSELS WERE COVERED DUE TO THE UNINTENDED DEPLOYMENT LOCATION. DURING WITHDRAWAL OF THE DELIVERY CATHETER, IT BECAME STUCK. REPEATED ATTEMPTS TO WITHDRAWAL WERE UNSUCCESSFUL. THE DECISION WAS MADE TO PULL BACK ON THE CATHETER. THE TIP OF THE BALLOON BROKE OFF AND REMAINED IN THE PATIENT AS 'ENDOTRASH'. ADDITIONALLY, THE INFLATION HUB OF THE CATHETER NEAR THE STRAIN RELIEF (OUTSIDE THE PATIENT) ALSO DETACHED. IT WAS REPORTED, IN ORDER TO REMEDY THE SITUATION, AN 8F DESTINATION SHEATH WAS TELESCOPED THROUGH THE 10F GORE® DRYSEAL FLEX SHEATH TO THE TARGET STENTING LOCATION IN THE IIA. AN ADDITIONAL 8L MM X 59 MM VBX DEVICE WAS ADVANCED AND DEPLOYED SUCCESSFULLY; STENTING THE DESIRED TARGET TREATMENT LENGTH AS WELL AS THE 'ENDOTRASH' LEFT BY THE BALLOON. IT WAS REPORTED THE CASE WAS COMPLETED SUCCESSFULLY, AND NO ADDITIONAL PROCEDURES WERE NECESSARY. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1158316 | GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS | ILIAC COVERED STENT, ARTERIAL | PRL | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male |