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

Catalog Number PXC121200

Device Problems Premature Activation (1484); Difficult to Remove (1528); Material Separation (1562); Physical Resistance (2578); Difficult to Advance (2920)

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

Event Date 02/16/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 a patient with an abdominal aortic aneurysm was treated with gore® excluder® aaa endoprostheses.Following deployment of the trunk ipsilateral leg endoprosthesis, an attempt was made to advance the sheath to the contralateral gate.It was not possible to advance the sheath to the gate, so the contralateral leg endoprosthesis was advanced over a wire.Resistance was met at the contralateral gate and the device was observed to self-deploy.When the delivery catheter was removed from the patient, it was noticed that the distal olive and segment of the catheter where the device was attached, were left in the patient.The catheter olive with catheter segment were successfully retrieved from the patient.The patient did well following the procedure.

Manufacturer Narrative

Additional devices used: dsl1828/13379221, dsl1628/13403206, pxl161207/13140269, rlt311417, pxc121400/13273994 and plc271000/13388507.Results: a review of the manufacturing records for the device verified the lot met all pre-release specifications.The imaging evaluation stated the proximal end of the trunk does not appear to be apposed to the right wall of the proximal neck, although no contrast is visible outside implanted either at the level of malapposition or distal to it.The following additional observations were made: (b)(6) 2014 pre-operative: aortic diameter just distal to the lowest renal appears to be 25mm average and 27mm maximum.Aortic diameter ~8mm distal to the lowest renal appears to be 25mm.Aortic diameter 15mm distal to the lowest renal appears to be 23mm average and 24mm maximum.There appears to be an irregular flow lumen at the level of the distal abdominal aorta.Right common iliac diameters appear to range from 17mm ¿ 26mm.Left common iliac diameters appear to range from 12mm ¿ 24mm.Right external iliac diameters appear to range from 10mm ¿ 21mm.Left external iliac diameters appear to range from 10mm ¿ 17mm.(b)(6) 2015 intraoperative: 10:56-11:01 the trunk appears to have been deployed just distal to the lowest renal artery.There appears to be poor wall apposition along the right side of the proximal neck.11:39 access appears to have been gained to the contra-lateral side of the trunk.The contra-lateral limb appears to have deployed distal to the contra-lateral ring, with no overlap between devices.11:39-11:41 after deployment of the contra-lateral limb, there appears to be a kink in the sheath on the left.11:59 an additional device appears to have been deployed bridging the contra-lateral limb and the contra-lateral side of the trunk.12:35 there appears to be poor wall apposition at the proximal end of the trunk.The right side of the trunk does not appear to be touching the aortic wall.No contrast is visualized outside of the devices, although this cannot be definitively confirmed because of limited number of available images in this series.12:37 final angio- no contrast is visualized outside of the devices, although this cannot be definitively confirmed because of limited number of available images in this series.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The engineering analysis stated the following: the leading end of the delivery catheter was fractured and polyimide guidewire lumen broken off at the trailing olive junction.The guidewire and the introducer sheath were not returned, therefore unavailable for engineering evaluation.The root cause for the premature deployment could not be determined based on the currently available information.The root cause for the difficulty to advance the device could not be determined with the currently available information.The root cause for the broken of the catheter could not be determined with the currently available information.However, use outside of the ifu was reported and likely contributed to the event.Conclusion code: the gore® excluder® aaa endoprosthesis instructions for use (ifu) clearly states: warning: do not advance the device outside of the sheath.The sheath will protect the device from catheter breakage or premature deployment while tracking it into position.Warning: do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.

• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4607005
• MDR Text Key: 5627738
• Report Number: 2953161-2015-00030
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2015

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: 11/30/2017
• Device Catalogue Number: PXC121200
• Device Lot Number: 13379028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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): Other; Required Intervention
• Patient Age: 82 YR