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

Catalog Number	PLL161407
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: plc231400/17851482, pla360400/16548410.
Event or Problem Description
On (b)(6) 2018, this patient underwent endovascular treatment and was implanted with a conformable gore® tag® thoracic endoprosthesis and gore® excluder® aaa endoprosthesis.It was reported that the patient was converted to open repair and the devices were explanted this same day.The devices were discarded at the site.
Additional Manufacturer Narrative
Event: corrected/additional information.
Event or Problem Description
There was no deficiency of the devices reported.
Event or Problem Description
On (b)(6) 2018, this patient underwent endovascular treatment for a ruptured left subclavian artery anerusym and was implanted with a conformable gore® tag® thoracic endoprosthesis and gore® excluder® aaa endoprosthesis.The patient tolerated the procedure.Later this same day the patient became unstable and was brought back into the operating room due to the occurrence of a new rupture.The patient was converted to open repair and the devices were explanted this same day.The devices were discarded at the site.There was deficiency of the devices reported.The patient tolerated the procedure and has follow up scheduled for (b)(6) 2018 with the physician.
Additional Manufacturer Narrative
D11: patient medications include but are not limited to: ventolin, amlodipine, aspirin, acetametophen.

• 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: 7658178
• Report Number: 3013164176-2018-00060
• Device Sequence Number: 122309
• Product Code: MIH
• UDI-Device Identifier: 00733132618767
• UDI-Public: 00733132618767
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2021
• Device Catalogue Number: PLL161407
• Device Lot Number: 17623836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/09/2018; 07/25/2018
• 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; Other; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 48