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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Necrosis (1971); Renal Failure (2041); Thrombosis/Thrombus (4440); Unspecified Musculoskeletal problem (4535)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The following article was reviewed: "morbidity and mortality following endovascular repair of abdominal aortic aneurysms in the elderly" daniel silverberg md, ahmad abu rmeileh md, daniel raskin md, uri rimon md and moshe halak md isr med assoc j.2020 jan;22(1):17-21 pmid: 31927800.Mean age was 84 ± 3.4 (range 80-96) years.The vast majority of the patients were male.The date of event remains unknown, therefore the date the literature was published was selected as the date of event.The device remains implanted in the patient.Additional information like patient data, serial number of the device, date of implant, onset date of the events, dicom imaging series, etc., was requested from the corresponding author.Answer pending.

Event Description

The following article was reviewed: "morbidity and mortality following endovascular repair of abdominal aortic aneurysms in the elderly" daniel silverberg md, ahmad abu rmeileh md, daniel raskin md, uri rimon md and moshe halak md isr med assoc j.2020 jan;22(1):17-21 pmid: 31927800.This retrospective study included 128 patients older than 80 years of age who underwent elective endovascular aneurysm repair of abdominal aortic aneurysms between 2007 and 2017.Mean age was 84 ± 3.4 (range 80-96) years, and 110 patients (86%) were male.The demographics, perioperative morbidity and mortality, and long-term results were reported.A gore® excluder® aaa endoprosthesis was used in 12 patients.Within the literature the following events, which occurred within 30 days after the intervention, were reported: three patients required re-intubations due to pulmonary complications (pneumonia, aspiration, or copd exacerbation) and eventually died.Two patients developed severe ischemic colitis.Both required emergency surgery and underwent colon resections and hartman procedures; however, the patients continued to deteriorate following the surgery and eventually died.Septic shock developed in one patient 5 days after the surgery, causing death.One patient died from cardiac arrest due to a coronary event.The gore device did not cause or contribute to these adverse events with those patients.The gore device might have caused or contribute to the following adverse events reported in the literature: events, which occurred within 30 days after the intervention: complaint 3199-1: the aorta of one patient ruptured during ballooning of the aortic neck at the end of the procedure resulting in massive bleeding.The patient did not recover and eventually died from multiorgan failure on postoperative day 4.Complaint 3199-2: one patient presented with massive distal embolization into his lower extremities and internal iliac arteries, developed rhabdomyolysis, buttock necrosis and renal failure.(code 5000-c:-other: rhabdomyolysis, buttock necrosis).Events, which occurred after more than 30 days after the intervention: complaint 3199-3: 8 patients required re-interventions of the aneurysm due to different types of endoleak and aneurysmal sac expansion during the follow up period.The majority of interventions were performed using endovascular techniques, while two required a sacotomy.Case 3221: one patient died from aneurysm rupture.This patient underwent evar in 2012, required re-intervention 2 years later due to a type 3 endoleak (complaint 3221-1) and was re-admitted due to a ruptured aneurysm, most probably due to an undetected type 1b endoleak (complaint 3221-2).

Event Description

The following article was reviewed "morbidity and mortality following endovascular repair of abdominal aortic aneurysms in the elderly" daniel silverberg md, ahmad abu rmeileh md, daniel raskin md, uri rimon md and moshe halak md.Isr med assoc j.2020 jan;22(1):17-21.Pmid: 31927800.This retrospective study included 128 patients older than 80 years of age who underwent elective endovascular aneurysm repair of abdominal aortic aneurysms between 2007 and 2017.Mean age was 84 ± 3.4 (range 80-96) years, and 110 patients (86%) were male.The demographics, perioperative morbidity and mortality, and long-term results were reported.A gore® excluder® aaa endoprosthesis was used in 12 patients.Within the literature the following events, which occurred within 30 days after the intervention, were reported: three patients required re-intubations due to pulmonary complications (pneumonia, aspiration, or copd exacerbation) and eventually died.Two patients developed severe ischemic colitis.Both required emergency surgery and underwent colon resections and hartman procedures; however, the patients continued to deteriorate following the surgery and eventually died.Septic shock developed in one patient 5 days after the surgery, causing death.One patient died from cardiac arrest due to a coronary event.The gore device did not cause or contribute to these adverse events with those patients.The gore device might have caused or contribute to the following adverse event reported in the literature: one patient presented with massive distal embolization into his lower extremities and internal iliac arteries, developed rhabdomyolysis, buttock necrosis and renal failure.

Manufacturer Narrative

The following article was reviewed "morbidity and mortality following endovascular repair of abdominal aortic aneurysms in the elderly" daniel silverberg md, ahmad abu rmeileh md, daniel raskin md, uri rimon md and moshe halak md.Isr med assoc j.2020 jan;22(1):17-21.Pmid: 31927800.In total four reports related to the reviewed literature were submitted: manufacturer report number 3007284313-2021-01265, manufacturer report number 3007284313-2021-01264, manufacturer report number 3007284313-2021-01266, manufacturer report number 3007284313-2021-01267.A1: the patient id was not provided.Therefor the gore complaint reference number was used.A2: the mean age of the study cohort was 84 years.A3: the vast majority the patients were male.B3: the exact event date remains unknown, therefore the date the literature was first published was used.H6-code 4535 and 1971: buttock necrosis.H6-code 4111: a request was emailed to the corresponding author to provide additional information like serial number, patient identifier, date of birth, age, weight, gender, name, date of implant, onset date of the events, potential reintervention, description of related procedures and intra- and postprocedural dicom angiography imaging series.H6-code 3221: the requested information was not provided.With no additional information provided, gore is unable to perform further investigations of the related complaints.H6-code 4117: the device remains implanted in the patient.Therefore, a device evaluation could not be performed.H6-code 4119: the serial number of the device remains unknown.Therefore, a review of the manufacturing record could not be performed.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11373773
• MDR Text Key: 242731890
• Report Number: 3007284313-2021-01266
• 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
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 84 YR