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

Catalog Number HGB161007

Device Problems Premature Activation (1484); Sticking (1597); Physical Resistance (2578)

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

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

Udi for gore® excluder® internal iliac component hgb161007: (b)(4).- the review of the manufacturing records verified that the lots involved in this event met all pre-release specifications.(b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2018, this patient underwent endovascular treatment presumably for an aneurysm of the common iliac artery and was treated with gore® excluder® aaa endoprostheses as well as gore® excluder® iliac branch endoprostheses.During the advancement of a gore® excluder® internal iliac component hgb161007 to the intended location, the device catheter became stuck in the patient¿s heavily calcified internal iliac artery and would neither move forwards nor backwards.To overcome the resistance, the catheter was retracted with force and the leading olive was noted to have become separated.With the olive detached, the catheter was again advanced and the hgb component was successfully deployed.The olive was retrieved by snaring technique and completely removed from the patient.Reportedly, the patient has been recovering well without ill effects.The calcified hypogastric artery was thought to have been contributing to the separation of the leading olive.

Manufacturer Narrative

The gore® excluder® internal iliac component hgb161007 / 17679823 was returned to gore and an engineering evaluation was performed.The device evaluation showed that the delivery catheter was broken at the trailing olive and that the leading end had pulled out of the trailing olive bond.The inside of the trailing olive had imprints from the polyimide guidewire lumen.The deployment line was extending out of the delivery catheter.When the introducer sheath was cut open, the stent graft was found deployed inside the introducer sheath.The leading end of the catheter was not inside the introducer sheath and the leading end of the catheter was not returned for evaluation.The findings from the evaluation are consistent with the physician¿s observations.The cause for the catheter breakage could not be determined with the available information.

Event Description

During the attempt to advance a gore® excluder® internal iliac component hgb161007 to the intended location, the device catheter became stuck due to a stenosis and heavy calcium deposit in the patient¿s internal iliac artery and would neither move forwards nor backwards.To overcome the resistance, the catheter was retracted with force and the ¿olive tip and a trail of wire¿ was noted to have become separated.Reportedly, the device did not deploy and was not in the sheath at this point.The device catheter was pulled back by snaring technique and the sheath was advanced to capture the olive and the trailing wire before snaring and removing them completely from the patient.Subsequently, the vessel stenosis was ballooned and a new internal iliac component was advanced to the intended location and successfully deployed.Reportedly, the patient has been recovering well without ill effects.The stenosed and calcified hypogastric artery was thought to have been contributing to the separation of the device catheter¿s proximal portion.

Manufacturer Narrative

Describe event or problem: updated previously provided information.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7603172
• MDR Text Key: 111839643
• Report Number: 3013164176-2018-00050
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2021
• Device Catalogue Number: HGB161007
• Device Lot Number: 17679823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/26/2018; 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR