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

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

The date the article was accepted by the journal was used as the event date, since no date of publication is known as of today.The patient age and patient gender reflect the mean age and gender stated in the article.(b)(4).

Event Description

The following publication was reviewed: ¿twenty-two year multicentre experience of late open conversions after endovascular abdominal aneurysm repair¿ (paolo perini et.Al, eur j vasc endovasc surg, accepted january 10, 2020).In the article ten vascular centers reviewed all patients requiring late open conversions (locs) after endovascular abdominal aneurysm repair (evar) from 1996 to 2017.Loc is defined as more or equal to 30 days after initial evar, undergoing total or partial endograft explantation.The article included a total of 232 patients and stated that 42 of them (18.1%) were initially treated with gore® excluder® aaa endoprostheses.It was stated that the main reason for loc was the presence of an endoleak in 80.2% (186/232) cases.Among these, 13 patients presented with endotension.The physician stated that the reported adverse events are related to disease progression.

• 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: joerg kersten ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9914722
• MDR Text Key: 188892596
• Report Number: 3007284313-2020-00089
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 74 YR