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

Catalog Number RMT261418

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Anemia (1706); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Thrombus (2101); Test Result (2695); No Code Available (3191)

Event Date 07/19/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).The concomitant medical products are three gore® excluder® aaa endoprosthesis (pxc121200/13287588, pxc141200 /13426725, pxc141400/13580484) and two gore® viabahn® endoprosthesis (vbc101002/12878005, vbc131002/13685144).The therapy date was (b)(6) 2015.The review of the manufacturing records verified that this lot met all pre-release specifications.

Event Description

It was reported to gore that on (b)(6) 2015 the patient was implanted with a gore excluder aaa endoprosthesis featuring c3 delivery system (rmt261418/12505275) and three gore excluder aaa endoprosthesis (pxc121200/13287588, pxc141200 /13426725, pxc141400/13580484) together with two gore viabahn endoprosthesis with for treatment of a massive aneurysm from the abdominal artery to the right femoral artery.Access for excluder devices was performed from the right femoral artery and two viabahn devices in the right femoral artery from the popliteal artery.It was stated that the right femoral artery aneurysm started to rupture before the operation and the conditions of blood vessel were poor.The post-deployment angiography reportedly showed a small type i endoleak from the distal portion of the gore viabahn endoprosthesis, but without endoleak in the proximal portion of the gore excluder aaa endoprosthesis.After the operation, it was stated that the patient experienced post-operative oligochromemia and a 1g decrease of hemachrome per day, but improved after clinical treatment by transfusion and drug administration.The bedside ultrasound on unknown date after the operation revealed peritoneal effusion.A mixed enclosed mass was revealed in the right upper abdomen, it is not clear of the source of the mass and needs further inspection to confirm.The abdominal aneurysm with thrombus was detected after the stent graft being implanted.The right femoral artery implanted with stent graft was detected with mixed enclosed mass.Both limb arteries were detected with atherosclerosis.On early (b)(6) 2015, the patient complained abdominal pain, the blood pressure dropped down sharply due to massive haemorrhage and the patient expired.The reason was reportedly uncertain.

Manufacturer Narrative

(b)(4).Per the instructions for use (ifu), the adverse events associated with the use of the gore excluder aaa endoprosthesis may occur but are not limited to endoleak and death.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5009487
• MDR Text Key: 23215878
• Report Number: 3007284313-2015-00087
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 08/26/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: RMT261418
• Device Lot Number: 12505275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• 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 Outcome(s): Death
• Patient Age: 83 YR
• Patient Weight: 75