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

Catalog Number HGB161207

Device Problems Bent (1059); Disconnection (1171); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: gore® excluder® iliac branch component (ceb): ceb231210/14326081; gore® excluder® internal iliac component (hgb): hgb161407/14937533.(b)(4).The review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.

Event Description

On (b)(6) 2016, the patient was implanted with gore® excluder® iliac branch endoprostheses (ceb) to treat an aneurysm of the right common iliac as well as the right internal iliac artery.After successful deployment of a ceb iliac branch component in the patient's right common iliac artery, extreme resistance was felt when advancing an (b)(4) internal iliac component through a dry seal flex sheath.Excessive force was applied in an attempt to advance the device past the resistance, at which point the physician was advised against as a wrapping of wires was suggested.After removing the device from the patient, the section between the leading olive tip and the graft appeared bent as it followed an extreme bend in the guidewire.In an attempt to forcibly remove the catheter from the guidewire, the leading olive separated.A new (b)(4) internal iliac component was advanced and placed past a sharp bend in the right internal iliac artery.Post placement, intra-operative imaging however revealed that the device had disconnected from the contralateral gate of the ceb component.Due to the patient's anatomy it was not possible to bridge the endoprostheses.Reportedly, both common iliac arteries presented with extensive bends and the dry seal flex sheath had to be repeatedly advanced into the contralateral gate.Due to the patient's anatomy, it was impossible to complete the ibe procedure.An aorto-uni-iliac bypass procedure was carried out with a medtronic device.The (b)(4) internal iliac component was discarded at the facility.

• 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
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: thomas giebing ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5765373
• MDR Text Key: 48719019
• Report Number: 2953161-2016-00131
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2019
• Device Catalogue Number: HGB161207
• Device Lot Number: 14973613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2016
• 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 Outcome(s): Hospitalization; Required Intervention