MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT231218J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

As it is unknown which gore® excluder® component(s) may have contributed to this event, the following devices will be included in this report: pll161207j/20612306, udi: (b)(4).Plc121400j/20934017, udi: (b)(4).A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to embolization (micro and macro) with transient or permanent ischemia.

Event Description

On (b)(6) 2019, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Significant thrombus was reportedly noted in the aneurysm prior to the procedure.During the procedure, a 12fr introducer sheath was inserted from the patient¿s left side, and a 16fr introducer sheath was inserted from the right side.According to the report, all endoprostheses were advanced and implanted successfully.When the physician attempted to close the access site, doppler ultrasound and procedural angiography reportedly showed that the arteries below the patient¿s left knee were embolized.The cause of the embolization was unknown.A thrombectomy was performed to the peroneal, anterior tibial, and posterior tibial arteries using a fogarty catheter.A percutaneous transluminal angioplasty (pta) was also performed to the anterior tibial artery using a 2mm balloon catheter.A final procedural angiograph reportedly showed blood flow below the knee was recovered, but a doppler ultrasound reportedly did not confirm recovery in comparison to blood flow before the thrombectomy and pta procedure.No further measures were taken, and the procedure was concluded.According to the report, the patient denied any numbness of the lower extremities after the procedure.The physician will continue to monitor the patient.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• 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: damon jackson ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9530999
• MDR Text Key: 188993230
• Report Number: 3007284313-2019-00398
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2022
• Device Catalogue Number: RLT231218J
• Device Lot Number: 21015980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR