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

Catalog Number PLC181200J

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

Patient Problem Occlusion (1984)

Event Date 11/11/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent an endovascular procedure using a gore® excluder® aaa endoprosthesis featuring c3® delivery system to repair an abdominal aortic aneurysm.Deployment of the proximal portion of the trunk-ipsilateral leg component (rlt311413j/13118059) and cannulation to the gate was successful.It was reported that while adjusting position of a contralateral leg component (plc181200j/13163072) by aligning the long markers, there was a resistance.After manipulating the delivery catheter up and down several times, it was noted that the proximal end of the device started to deploy without pulling the deployment line.The device was finally fully deployed distal to the intended position, unintentionally covering the right internal iliac artery.The delivery catheter was then removed from the patient and it was observed that the leading end of the delivery catheter was detached at the trailing olive.As the detached leading end remained in the patient, it was retracted using a snare catheter.Another contralateral leg component (plc181000j/unk) was additionally implanted to bridge the gate and the device.The procedure continued and all the devices were implanted without any further reported issues.The final angiography showed no endoleak, and the right internal iliac artery remained covered without any treatment.The patient tolerated the procedure.The physician commented that the delivery catheter of plc181200j/13163072 might have been manipulated and removed with its leading end stuck at calcification or edge of the sheath, resulting in the detachment.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The root cause for the premature deployment could not be determined with the currently available information.The root cause for the polyimide guidewire shaft separation from the catheter could not be determined with the currently available information.Additional manufacturer narrative - the device evaluation showed the following: only the delivery catheter of the contralateral leg component was returned for evaluation.Blood residue was observed on the throughout the delivery catheter.The polyimide guidewire lumen shaft had pulled out of the trailing olive bond on the catheter.Engineering was able to visually confirm that there was evidence of bonding between the polyimide guidewire lumen shaft and the leading olive.No damage was seen on the trailing olive, leading olive or the catheter body.The deployment knob was still screwed in the deliver catheter.The guidewire and introducer sheath were not returned and could not be evaluated.

• 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: miyuki kurihara ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4295961
• MDR Text Key: 5271683
• Report Number: 2953161-2014-00149
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2015

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: 09/30/2017
• Device Catalogue Number: PLC181200J
• Device Lot Number: 13163072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• 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): Life Threatening; Disability
• Patient Age: 75 YR