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

Model Number	PLC231000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020 the patient underwent endovascular repair of a right iliac artery aneurysm using gore® excluder® aaa endoprostheses.It was noted that there was dissection of the patient's left iliac artery.It was reported that the gore® excluder® aaa trunk-ipsilateral leg and contralateral leg components were advanced and deployed with no reported issues.Reportedly, a gore® molding & occlusion balloon (mob) catheter was used to balloon the contralateral leg component, located on the patient's left side.Upon inflation of the mob catheter, the patient's left iliac artery was ruptured.The physician and clinical specialist reported that iliac artery rupture was due to over ballooning.Reportedly there was no issue with either the gore® excluder® aaa contralateral leg component, or the mob catheter.The patient adverse event occurred solely due to over ballooning.The physician converted to an open procedure.The contralateral leg component was removed.The trunk-ipsilateral leg component remained in the patient.The patient's left iliac artery was clamped and sutured, and a right femoral to left femoral artery bypass was performed.The mob catheter was discarded at the facility.The contralateral leg component was returned for evaluation.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
Additional devices included in this adverse event include gore® molding & occlusion balloon catheter (item#: unk / lot#: unk / udi#: unk) which is captured in manufacturer report#: 3007284313-2020-00143.H.6.Results code 2 updated.H.6.Results code 2: code 213 - the engineering evaluation showed the following: the deployed endoprosthesis was returned for evaluation.No damage or anomalies on the endoprosthesis were noted that would contribute to the event.H.6.Conclusions code 1 updated.H.6.Conclusions code 2 added.According to the gore® molding & occlusion balloon catheter instructions for use (ifu), adverse events which may require intervention include, but are not limited to, trauma to the vessel wall such as perforation or rupture.Furthermore, the ifu cautions users to not inflate the balloon to a diameter larger than the vessel it is being inflated within.To avoid vessel trauma, do not over-inflate the balloon in relation to the diameter of the vessel or other devices.

• 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: 10121547
• Report Number: 3013164176-2020-00075
• Device Sequence Number: 16673145
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: PLC231000
• Device Catalogue Number: PLC231000
• Device Lot Number: 20900215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OMEGA 3, PRILOSEC, CLARITIN, MELATONIN, MYRBETRIQ
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 88