MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

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

Patient Problem Thrombocytopenia (4431)

Event Date 01/05/2023

Event Type  Death  

Event Description

Within the article ¿in situ laser fenestrations of aortic endografts for emergent aortic disease¿ published by anastasia dean et al.In the annals of vascular surgery 2023, in press, page 1-9 the following was indicated: in situ laser fenestration (islf) is a novel endovascular technique which allows customization of a standard stent graft to a patient's anatomy.While most reported cases involve revascularization of the left subclavian artery (lsa), some centers have now reported their initial experience treating branches of the visceral aorta for aortic aneurysms.The aim of this study is to examine the adoption of islf in emergent aortic pathology at a specialized aortic center.Between december 2020 and february 2022, all patients who underwent islf as part of endovascular intervention for complex aortic pathology at a university hospital were identified.Cases were collected from a prospective aortic database with additional information obtained from a retrospective review of electronic hospital records.Fifteen patients (11 men and 4 women) underwent emergency islf, with a median age of 76 years.Eleven presented with symptomatic or ruptured aortic aneurysms, three with acute complicated aortic dissections and 1 aortic traumatic transection.Most aortic aneurysms were thoraco-abdominal (n = 7), with 1 arch, 1 thoracic, 1 supra-renal, and one-juxta-renal aortic aneurysm.Islf was performed to revascularize the lsa in 8 cases, and branches of the reno-visceral aorta in 7 cases.All lsa islf cases had left brachial artery exposure.Femoral access was percutaneous in 14 of 15 cases.Technical success was 96.3% (26/27)).Median ischemic times were: superior mesenteric artery 7 min, renal arteries 22 min, and celiac trunk 43.5 min.There were 2 early aortic/fenestration related reinterventions.There was no stroke and 1 death caused by heparin-induced thrombocytopenia within 30 days.The majority of patients did not require intensive care admission (n = 8).The median intensive care unit stay was 0 days and hospital length of stay 18 days.There was no fenestration endoleak or reintervention post discharge with a median follow-up of 168 days.The following complication was indicated: in the short-term, one patient died within 30 days from complications (intra-cranial bleeding) arising from heparin-induced thrombocytopenia.This patient had received both systematic heparins during the procedure and placement of a heparin-bonded covered stent (gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device)) to bridge the fenestration.According to the reported information, the physician was not able to determine to what extent the heparin in the vbx-device could have contributed to the complications, therefore it was determined to reline the vbx-device with another stent and to exclude it from the circulation.

Manufacturer Narrative

Patient identifier: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Age or date of birth/sex: the patients mean age was 76 years and the gender male, as stated in the article.Outcomes attributed to adverse event: date of patient death is unknown.Date of event: date of event was determined as date when literature article was accepted, here (b)(6) 2023.Implant date: implant date is unknown.Further details were requested from the corresponding author such as serial no., implant date, date of event patient id, age, gender and weight, medical history of patient, possible root causes of heparin induced thrombocytopenia (hit) and the dose and interval of heparin injected into the patient.Until now no further information was provided.Product history review: a review of the manufacturing records for the device could not be conducted because the serial/lot number was not provided yet.Device evaluated by mfr: as the status of the device is unknown and it was not made available until now, a further investigation cannot be conducted.Evaluation codes: type of investigation: additional information in regard to the event of the case was requested from the physician.The provided additional information is captured in the event description.Cbas® heparin surface incorporates carmeda-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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

Product history review: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.As the status of the device remains unknown, an investigation of the device cannot be performed.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.In the period from end of (b)(6) 2023 until end of (b)(6) 2023 further details were requested from the corresponding author multiple times, such as serial no., implant date, date of event, patient id, age, gender and weight, medical history of patient, possible root cause of heparin induced thrombocytopenia (hit) and the dose and interval of heparin injected into the patient.No further information was provided.With the information provided to gore, the cause of the reported event could not be established.H6 evaluation codes investigation findings c20 was selected because no device investigation was able to be performed as no further information was able to be obtained from the authors (despite multiple attempts) and we did not receive the device and/or images back for evaluation.As no further information was received from the author, this investigation is considered complete, the cause of the complaint was unable to be determined.In the instruction for use for the gore® viabahn® vbx balloon expandable endoprosthesis the following is stated: adverse events potential clinical and device adverse events possible adverse events and complications that may occur with the use of this device or in any endovascular procedure and require intervention include, but are not limited to: death; allergic reaction and/or anaphylactoid response to x-ray contrast dye anti-platelet therapy.Contraindications do not use the gore® viabahn® vbx balloon expandable endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of heparin-induced thrombocytopenia (hit) type ii.A possible complication which may occur in conjunction with the use of any heparin-containing product: hit type ii (see warnings).Warnings do not use the gore® viabahn® vbx balloon expandable endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of hit type ii.With any vascular procedure, the possibility of hit may exist.The incidence of hit type ii is extremely low in vascular patients receiving heparin over a period of several days.If hit type ii is diagnosed, established procedures for the treatment of this condition, including immediate cessation of systemic heparin administration, should be followed.If symptoms persist, or the health of the patient appears compromised, alternative pharmaceutical or surgical procedures, including ligation or removal of the device, may be considered at the discretion of the attending physician.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16334470
• MDR Text Key: 309143445
• Report Number: 2017233-2023-03705
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 04/27/2023
• 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
• Treatment: COOK ZENITH ALPHA AND ZENITH TX2, ENDURANT II MEDT.
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Male