MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number PLC121400

Device Problems Break (1069); Material Separation (1562); Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The following investigation is planned: engineering evaluation of the delivery system which is currently in transit to manufacturer.A review of the manufacturing records indicated the lot met all pre-release specifications.The initial reporter has been contacted in order to receive more information on the event and patient details.

Event Description

It was reported to gore that during an implant of a gore® excluder® aaa endoprosthesis, the tip (the olive) of the contralateral leg endoprosthesis (plc121400) was disconnected from the shaft while the physician was retrieving the system after the deployment.The tip came out from the patient with the catheter and there were no issues for the patient.

Manufacturer Narrative

B3: the exact date of event is unknown, therefore the manufacturer awareness date was used.The gore® excluder® aaa endoprosthesis has been returned to manufacturer.Engineering evaluation of the device showed the following: -the packaging sheath had been removed from the device.The packaging mandrel had also been removed from the device.The packaging materials were not returned for evaluation.-the leading end of the delivery catheter guidewire lumen was stretched and creating a 38 mm gap between the leading olive and the constrained stent graft.The polyimide guidewire lumen was still bonded to both leading and trailing olives.-no abnormality was noted regarding the position of the stent graft to the trailing olive.-damage including what appeared to be abrasions and bend were observed on the outside of the polyimide guidewire where the polyimide guidewire lumen was stretched.-damage noted around the entire circumference of the leading olive.-a small piece of a broken guidewire was stuck inside the guidewire lumen at the leading olive.Engineering was unable to remove the small piece of the broken guidewire.-the device could not be loaded onto the guidewire through the hub due to a crystalline deposit that blocked the guidewire lumen at the catheter¿s hub.The findings from the evaluation are consistent with the reported observation that the tip of the device is positioned away from the graft instead of close to the graft.The reported observation that the resistance was noticed during advancement and withdrawal of the device could not be confirmed in the device evaluation.The cause for the damage to the leading olive and polyimide guidewire lumen as well as the gap between the trailing olive and the constrained stent graft could not be determined with the currently available information.The cause for the resistance during advancement and withdrawal of the device could not be determined with the currently available information.The excluder aaa instructions for use (ifu) clearly states: -do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.-do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter separation and reintervention.Updated b5: describe event or problem.Corrected h6: added health effect - impact code f2301 - additional device required.Updated medical device problem code to a0413 - material separation, code 1069 should be removed as it was inadvertently entered.Updated investigation findings code to c19 - no device problem found.Code 3233 is no longer applicable.Updated investigation conclusions code to d15 and d12.Code 11 is no longer applicable.

Event Description

It was reported to gore that during an implant of a gore® excluder® aaa endoprosthesis, the tip (the olive) of the contralateral leg endoprosthesis (plc121400) seem to be positioned away from the graft instead of close to the graft.The physician decided to remove the device from the patient undeployed.Resistance was noticed during advancement and withdrawal of the device, but it is not believed that the olive was caught on the end of the sheath.The olive came out from the patient with the catheter still on the guidewire and there were no issues for the patient.Another gore® excluder® aaa endoprosthesis device was successfully implanted.

Manufacturer Narrative

Based on the findings from the engineering evaluation, the reported stretching of the tip of the device does not indicate that the gore device meet the definition of a reportable malfunction.In addition, there wasn¿t any reported impact or injury to the patient.Therefore, this event is considered not reportable.The information provided is a known and foreseeable risk that is captured in our risk management documents.In addition, this type of events will be tracked as well as included in our trend analysis reports.

Manufacturer Narrative

Corrected h6: updated medical device problem code to a040611 - stretched, code a0413 should be removed as it was inadvertently entered.Updated investigation findings code to c0706 - stress problem identified, code c19 should be removed as it was inadvertently entered.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14268867
• MDR Text Key: 290965767
• Report Number: 3013164176-2022-01362
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: 00733132618644
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLC121400
• Device Catalogue Number: PLC121400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other