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

Catalog Number	PXC201000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: it is unknown which devices are related to the event, therefore all of the devices are being investigated.Additional devices potentially related to event: pxc161200, lot # 10297679, udi: (b)(4), pxc141200, lot # 10310492, udi: (b)(4), pxt231414, lot # 10170403, udi: (b)(4), pxt311413, lot # 10206380, udi: (b)(4), pxc141200, lot # 10408328, udi: (b)(4).
Event or Problem Description
The following information was reported to gore: on (b)(6) 2012 a patient underwent treatment of a thoracoabdominal aortic aneurysm measuring 57mm with gore® excluder® aaa endoprostheses.On (b)(6) 2019 a ct showed the aneurysm measured 95mm.On (b)(6) 2019 a rupture of the abdominal aortic aneurysm was recognized and a conversion to open repair was performed.Type ii and iii endoleaks were reported.The type ii endoleak from a lumbar artery was addressed by suture closure using a double needle 3-0 prolene suture, 2.2.The type iii endoleak was addressed with two contralateral leg components.On (b)(6) 2019 the patient expired.The cause of death was reported as cardiac arrest, due to a cardiac complication following angioplasty.
Additional Manufacturer Narrative
Results code 2.Imaging evaluation results: 08/10/2012 max diameter ~ 56mm x 62mm pre-operative images 10/08/2012 max diameter approximately 56mm x 63mm only non-contrast images are available for evaluation 06/05/2014 max diameter approximately 62mm x 64mm only non-contrast images are available for evaluation 10/06/2016 max diameter approximately 66mm x 76mm only non-contrast images are available for evaluation 02/07/2019 max diameter approximately 80mm x 103mm only non-contrast images are available for evaluation 02/28/2019 max diameter approximately 80mm x 103mm non-contrast, arterial and delay phase are available for evaluation.02/07/2019 only non-contrast images are available for evaluation.Unable to confirm the presence of a type ii or type iii endoleak with available image set.02/28/2019 non-contrast, arterial and delay phase are available for evaluation.No contrast is seen pooling outside of the implanted device.Patent lumbar artery is present.There appears to be ~ 3.2 cm of overlap in the contralateral side of the proximal trunk.There appears to be ~ 3.1 cm of overlap in the contralateral side of the distal trunk.
Event or Problem Description
On (b)(6) 2012 a patient underwent treatment of a thoracoabdominal aortic aneurysm measuring 57mm with gore® excluder® aaa endoprostheses.On (b)(6), 2019 the patient underwent an open surgical procedure to treat a type ii endoleak whereby lumbar arteries were ligated, and suture of the aneurysm, which had ruptured.This treatment was an off label technique.On (b)(6) 2019 a ct showed the aneurysm measured 95mm.On (b)(6) 2019 a rupture of the abdominal aortic aneurysm was recognized and a conversion to open repair was performed, additionally type ii and iii endoleaks were reported.The type ii endoleak from a lumbar artery was addressed by suture closure using a double needle 3-0 prolene suture, 2.2.The type iii endoleak, which was an unspecified component disconnect, was addressed with implanting two contralateral leg components.On (b)(6) 2019 the patient expired.The cause of death was reported as cardiac arrest, due to a cardiac complication (acute coronary syndrome) treated by angioplasty.No further information was provided.
Additional Manufacturer Narrative
B.5.Updated.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8489649
• Report Number: 3007284313-2019-00099
• Device Sequence Number: 2798427
• Product Code: MIH
• UDI-Device Identifier: 00733132610037
• UDI-Public: 00733132610037
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2019

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: 01/31/2015
• Device Catalogue Number: PXC201000
• Device Lot Number: 10004245
• 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: 04/05/2019
• Supplement Report FDA Received Date: 06/25/2019; 08/02/2019
• 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: 67 YR
• Patient Weight: 78