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

Catalog Number RLT281412

Device Problems Difficult to Remove (1528); Sticking (1597); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The device has been returned to gore for evaluation.The investigation showed the following: - the polyimide in the leading end of the delivery catheter showed signs of torsion.The remainder of the catheter appeared undamaged.- damage and scrapes were noted on the guidewire near the leading olive.- engineering attempted to push the guidewire from the touhy-borst valve through the catheter to mimic the removal of the device, but was unable to do so.However engineering was able to pull the guidewire out of the touhy-borst valve, mimicking advancement of the device.- based on the findings from the evaluation, the physician¿s observation that the delivery system became stuck on the guidewire and was not able to be removed, was confirmed.- the cause for the delivery system getting stuck on the guidewire and being unable to be removed during this event could not be determined with the currently available information.

Event Description

The following was reported to gore: on (b)(6) 2017, the patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.After successful implantation of the trunk-ipsilateral leg endoprosthesis, it was not possible to remove the device catheter back over a cook lunderquist 0.0035¿ guidewire.After not having moved the guidewire for approx.30min, the catheter was stuck on the guidewire and it was necessary to retract both items together out of the patient and to advance a new guidewire.The physician assumes that minor blood residue on the guidewire might have caused the issue.The implantation concluded as planned with successful exclusion of the aneurysm.The patient tolerated the procedure.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: joerg kersten ; 9285263030
• MDR Report Key: 6295702
• MDR Text Key: 66657389
• Report Number: 3007284313-2017-00025
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Catalogue Number: RLT281412
• Device Lot Number: 15506657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• 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 Age: 76 YR