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

Catalog Number PXC141400

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

Lot 13865213: (b)(4).

Event Description

On (b)(6) 2015, the patient was implanted with gorexcluderaa endoprostheses to treat an emergent abdominal aortic aneurysm.It was reported a cook sheath 12fr was being used and upon retracting the plc181400 device the distal olive became separated from the delivery catheter.The physician was able to snare and retrieve the olive with no injury to the patient.The patient tolerated the procedure.

Manufacturer Narrative

Lot 13244681: (b)(4).

Manufacturer Narrative

Upon further investigation it was determined the plc181400/13865213 device did not have any allegation of deficiency.Lot#13244681.(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The pxc141400 and pxc141000 devices were returned to gore for evaluation.The device evaluation for the pxc141400 device showed the following: only the catheter was returned.The packaging mandrel and packaging sheaths were not returned and could not be evaluated.The catheter had blood residue on it indicating it was the device that was used in the procedure.The leading end of the catheter had separated from the catheter body at the trailing olive.The guidewire lumen had fractured at the trailing olive bond on the catheter.There was a twist in the guidewire lumen which is indicative of the device being rotated.The device evaluation for the pxc141000 device showed the following: only the catheter was returned.The device had been deployed.The deployed device and deployment line were not returned and could not be evaluated.The packaging mandrel and packaging sheaths were not returned and could not be evaluated.There was no blood on the catheter, indicating that the device had not been used in the procedure.The leading end of the catheter had separated from the catheter body at the trailing olive.The guidewire lumen had fractured at the trailing olive bond on the catheter.The findings from the evaluation are consistent with the physician¿s observations.The root cause for the broken leading end of the catheters could not be determined with the currently available information.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states: do not rotate the contralateral leg delivery catheter during delivery, positioning or deployment.Catheter breakage or premature deployment may occur.

Event Description

It was reported a cook sheath 12fr was being used and upon retracting the pxc141400 device the distal olive became separated from the delivery catheter.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• 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: 5338635
• MDR Text Key: 35259649
• Report Number: 3007284313-2015-00146
• 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,Followup
• Report Date: 02/10/2016

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: 10/31/2017
• Device Catalogue Number: PXC141400
• Device Lot Number: 13244681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2016; 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2014
• 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 Age: 72 YR