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

Catalog Number	PLC121200
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018, this patient underwent endovascular treatment presumably for an abdominal aortic aneurysm (aaa) and was treated with gore® excluder® aaa endoprostheses.Having performed initial deployment of a gore® excluder® trunk-ipsilateral leg component, the physician advanced a 12 french gore® dryseal sheath through the contralateral gate on the left patient side.To confirm the location of the internal iliac artery during intra-operative imaging, the sheath was again retracted to the level of the iliac artery axis.However, it had also been noticed that the radiopaque marker ring of the contralateral gate was not oriented as typically and appeared tilted towards the anterior.Following consultation with the field sales associate attending the procedure, the physician decided to advance the contralateral leg component plc121200 to the intended location outside of the sheath.When the plc121200 endoprosthesis was subsequently transversed through the 12 french dryseal sheath, the device catheter¿s leading olive got caught at the edge of the contralateral gate and would not pass through.In an attempt to free the olive, the catheter was retracted and it was found that the olive was not directed towards the contralateral leg hole.During a second insertion attempt, the proximal portion of the device catheter would no longer show any movement and the leading end was observed to have been separated.It was concluded that the rim of the introducer had cut the device catheter below the device, leaving the deployment line as the only connection between the device and the device catheter.After several snaring attempts, the leading end was successfully brought into the left femoral artery.As the approach had been percutaneous, an arteriotomy of the femoral artery was performed to completely remove the leading end from the patient.A new contralateral leg component was implanted and the procedure concluded as planned.
Additional Manufacturer Narrative
B1: changed to adverse event and product problem.H1: changed to malfunction and serious injury.
Additional Manufacturer Narrative
H1: changed to serious injury.
Additional Manufacturer Narrative
H1.Type of reportable event: changed to serious injury.The gore® excluder® contralateral leg component plc121200 / 16558692 was returned to gore and an engineering evaluation was performed.The device evaluation showed that the delivery catheter was broken at the trailing olive.The leading end had fractured at the trailing olive.The deployment knob had been removed from the catheter.The deployment knob with attached deployment line was not returned for evaluation.A length of deployment line was still attached to the device broken off from the leading end of the catheter.The device was partially deployed at the leading end.The findings from the evaluation are consistent with the physician¿s observations.The cause for the catheter breakage could not be determined with the available information.The advancement of the undeployed device outside of the introducer sheath may have contributed to the event.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7771856
• Report Number: 3013164176-2018-00073
• Device Sequence Number: 13800833
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: PLC121200
• Device Lot Number: 16558692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 09/10/2018; 10/31/2018; 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 65 YR
• Patient Weight: 91