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

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

Patient Problem Wound Dehiscence (1154)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

Date the incident occurred is unknown, so the date of acceptance of the manuscript by the journal was used.

Event Description

The accepted manuscript ¿outcomes of the repair of 1000 abdominal aortic aneurysms in the endovascular era, annals of vascular surgery (2019), by s.Revuelta et.Al, accepted by the journal on december 20, 2018, analyzed the outcome of abdominal aortic aneurysm (aaa) repair with elective open surgery (os) versus endovascular aneurysm repair (evar), and to assess the predictors of survival.A retrospective cohort study was made of 1000 aaa treated between january 1998 and november 2014 (68.1% os and 31.9% evar), with the comparison of comorbidity and complications, and survival analysis.A total of 1000 cases of aaa were treated on an elective basis.Of these, 681 corresponded to os and 319 to evar.The gore® excluder® aaa endoprosthesis was the most commonly used stent graft in the evar group, with 263 cases (82.5 %).In 21 cases (6.6%) the medtronic talent¿ was used, in 16 cases (5.0%) different versions of cook® zenith® were used and in 19 cases the boston scientific vanguard¿, medtronic endurant¿, the vascutek anaconda¿ and the medtronic aneurx aaadvantage® were implanted.An aorto uniiliac stent graft was used in 23 cases (7.2%).Among other adverse events the article states that there were two late surgical wound complications that required reintervention.The article is not specific in regards to which of the implanted device was involved in the reported adverse events.

Manufacturer Narrative

B4: corrected.

• 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
• MDR Report Key: 8462070
• MDR Text Key: 140284250
• Report Number: 2017233-2019-00181
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR