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

Model Number PXT281412

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Ruptured Aneurysm (4436)

Event Date 10/17/2022

Event Type  Injury  

Event Description

The following was captured in a historical record: on (b)(6) 2008, the patient underwent treatment of an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis trunk-ipsilateral leg component and two contralateral leg components on (b)(6) 2013, follow-up imaging identified an unspecified endoleak with aneurysm enlargement of an unknown amount.According to the physician, the endoleak was identified as a type ii endoleak with the source multiple lumbar arteries.On (b)(6) 2013, the patient was implanted with gore® excluder® aaa endoprosthesis contralateral leg component (plc181000, sn:(b)(4)).Medical records indicate that in 2013 a ct was performed and the maximum aneurysm sac measured 7.4 x 6.6cms.On (b)(6) 2016, the patient was implanted with a gore® excluder® aaa endoprosthesis aortic extender (mpdcase-00011054) medical records indicate that on (b)(6) 2016 a ct was performed and the maximum aneurysm sac measured 8.8 x 7.2cms.On (b)(6) 2017 a ct was performed and the maximum aneurysm sac measured 8.9 x 8.1cms.On (b)(6) 2019, a ct was performed and the maximum aneurysm sac measured 9.8 x 8.6cms.The following is new information: as reported by the fsa, on (b)(6) 2022, the patient suffered a rupture.As reported, a type iii endoleak was observed in which a previously implanted contralateral limb was observed to be partially out of the trunk gate.A type ib was also observed down the right side of the patient.The patient underwent a reintervention in which they were implanted with a plc121400 and a plc121000 from the flow divider to the right external iliac.As reported, the aneurysm had grown to an extent that there was no longer a distal seal on the previously implanted device.Patient imaging was provided for consideration and review.The imaging evaluation showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2022.Contrast is pooling in the aneurysm sac.There is a disconnection of the proximal contralateral leg at the contralateral gate, thereby confirming a type iii endoleak.Maximum aaa diameter on this time-point appears to be 12.1cm x 13.4cm.This finding is consistent with the description summary of aneurysm growth.Contrast is visualized in a set of lumbar arteries, at a level of the implanted proximal device trunk, communicating with contrast pooling in the sac.Cannot confirm ante grade or retrograde flow.Therefore, cannot confirm a type ii endoleak involving lumbar arteries.There appears to be 2mm of seal in the distal contralateral leg in the rci.Rci diameters within this 2mm of vessel appear to range from 19.8mm ¿ 20.7mm.Contrast is not visualized pooling outside the limb in the sac, therefore, cannot confirm a type ib endoleak from this set of images.There are multiple levels of cta imaging that have unclear aneurysm borders with consistent densities around the outside of the anterior half of the sac.This finding is consistent with the description summary of a ruptured aortic aneurysm.

Manufacturer Narrative

The following patient information was requested but was not provided: patient weight.Past medical history: a-fib, aaa (abdominal aortic aneurysm), acute but ill-defined cerebrovascular disease, aicd (automatic cardioverter/defibrillator present, aneurysm, aortic valve disorder, arthralgia, cad (coronary artery disease) severe multi vessel, cataract, cervicalgia, chronic systolic (congestive) heart failure, copd (chronic obstructive pulmonary disease), gastroesophogeal reflux disease with hiatal hernia, gerd with apnea, htn (hypertension), hx of cabg x 4, hypercholesteraemia, ischemic cardiomyopathy, peripheral neuropathy, peripheral vascular disease, prostate troubles, shortness of breath.Past surgical history: sinus surgery, coronary artery bypass graft (l-lad, s-d1, s-pda/om), pacemaker insertion, colonoscopy, upper gastrointestinal endoscopy, cardiac defibrillator placement, pacemaker insertion, abdominal aortic aneurysm repair (endovascular), cataract removal with implant, cervical spine surgery, coronary angioplasty with stent placement, foot surgery, tonsillectomy medications: sodium chloride 0.9%, 10ml, intravenous, once blood loss from rupture: 800ml.Operative blood loss treating rupture: 50ml.Social history: former smoker.No allergies.As gore was unable to determine which device(s) caused or contributed to the event if any; additional device(s) implanted related to this event include the following as referenced in 11048-2, 11048-3, and 11048-4 11048-2: brand: gore® excluder® aaa endoprosthesis, product name: stent graft contralateral leg, catalog number: pxc181200, lot/sn: (b)(4), udi: (b)(4).11048-3: brand: gore® excluder® aaa endoprosthesis, product name: stent graft contralateral leg, catalog number: pxc181000, lot/sn: (b)(4), udi: (b)(4).11048-4: brand: gore® excluder® aaa endoprosthesis, product name: stent graft contralateral leg, catalog number: plc181000, lot/sn: (b)(4), udi: (b)(4).(b)(4).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.

Manufacturer Narrative

H6.Code c19, no device problem found: a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.H6.Code d12, known inherent risk of device: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to endoleak and aneurysm enlargement.B2.Outcomes populated.Previously blank.G3/g4.Date received by manufacturer updated to 29-nov-2022 as manufacturing evaluations were completed in full on this date.H6.Code c21, results pending completion of investigation was replaced with findings.H6.Code d16, conclusion not yet available replaced with conclusions.

• 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
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15786068
• MDR Text Key: 303939970
• Report Number: 2017233-2022-03476
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132610297
• UDI-Public: 00733132610297
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/06/2022

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: 11/30/2010
• Device Model Number: PXT281412
• Device Catalogue Number: PXT281412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/13/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2007
• 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; Other; Life Threatening
• Patient Age: 85 YR
• Patient Sex: Male