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

Catalog Number PLC271000

Device Problems Difficult To Position (1467); Premature Activation (1484); Physical Resistance (2578)

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

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

On an unknown date, the patient was implanted with a cook endoprostheses to treat an abdominal aortic aneurysm.Images (date and modality is unknown) revealed a distal type i endoleak in the right limb and the physician chose to reintervene and use a gore excluder aaa endoprosthesis (plc271000/13801352) on (b)(6) 2015.It was reported the physician attempted to canulate the existing cook limb of the device with a 16fr dryseal sheath, but he was approximately 2cm short of doing so.He decided to bareback the plc271000 device.He was unable to get the plc271000 device into position due to resistance.During one of the attempts the device deployed unintentionally inside the sheath.The physician decided to retract the sheath and the device from the patient and use a new one (the dsl 16fr that was being used, the lot and serial number is unknown).Both the sheath and the partially deployed device was removed from the patient.When the clinical specialist inspected the removed device, he noticed the distal olive was missing.Under angio the olive was inside the patient on the guidewire, and the olive had become separated from the delivery device.The physician snared the olive to remove it from the patient.A new plc271000 device and a new dryseal 18fr sheath was used to complete the procedure.There was no further sequela and the patient tolerated the procedure.

Manufacturer Narrative

(b)(4) - the device was returned to gore engineering for evaluation.The returned product exhibited polyimide guidewire lumen fracture at the leading end of the trailing olive junction.It appeared that the fracture was due to a polyimide guidewire lumen¿s torsional failure while the trailing olive junction remained intact.The review of the lot history record verified that the lot met the pre-released specification and the acceptance criteria.The guidewire and the introducer sheath used for the event were not returned, and therefore unavailable for engineering evaluation.Based on the available information and evaluation of the returned portion of the product, the root cause for the polyimide fracture could not be determined at this time.However, use outside of the ifu was noted and may have contributed to this event.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: rachael chascsa ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 4987497
• MDR Text Key: 23845605
• Report Number: 2953161-2015-00086
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 08/25/2015

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: 03/31/2018
• Device Catalogue Number: PLC271000
• Device Lot Number: 13801352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 82