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

Catalog Number PXC121200

Device Problems Detachment Of Device Component (1104); Unintended Collision (1429); Retraction Problem (1536); Physical Resistance (2578); Difficult to Advance (2920)

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

Event Date 05/18/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient reportedly had tortuous anatomy.It was reported the physician elected to canulate the contralateral gate ¿bareback¿.A cook 12fr sheath was being used for the procedure.The physician was attempting to canulate the contralateral gate and felt some resistance and the device got caught on something.However, he was able to canulate the gate and successfully deploy the device.Upon retracting the delivery catheter the physician noticed the olive had become separated from the delivery device, he snared the olive to remove it from the patient.The olive was removed from the patient, and the procedure concluded with no further issue.The patient tolerated the procedure.

Manufacturer Narrative

Medications: multivitamins, advair, cozaar, furosemide, vitamin d, glucotrol, hydrochlorothiazide, januvia, detrol, zocor, and metoprolol.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

The device was returned to gore for evaluation, per gore engineering the evaluation revealed the guidewire was not returned, therefore unavailable for engineering evaluation.The returned product showed that the polyimide guidewire lumen detachment at the leading end of the trailing olive junction.Based on the available information and evaluation of the returned portion of the product, no root cause could be determined at this time.However, use outside of the ifu was noted and may have contributed to this event.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), the warnings and precautions section of the ifu 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.¿ the warnings and precautions section of the ifu also states, ¿do not attempt to withdraw any undeployed endoprosthesis through the 12 fr, 18 fr or 20 fr introducer sheath.The sheath and catheter must be removed together.¿ further the ifu states, ¿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: rachael chascsa ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4846335
• MDR Text Key: 5812865
• Report Number: 2953161-2015-00062
• 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
• Type of Report: Initial,Followup
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: PXC121200
• Device Lot Number: 11689680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• 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
• Patient Age: 82 YR
• Patient Weight: 77