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

Catalog Number BXAL085902E

Device Problem Partial Blockage (1065)

Patient Problems Coagulation Disorder (1779); Thrombus (2101); Stenosis (2263)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

The instructions for use states the following: ¿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.".

Event Description

The patient presented with a diseased lesion within the abdominal aorta.To treat the lesion, three gore® viabahn® vbx balloon expandable endoprostheses were implanted at the level of the bifurcation in the aorta/common iliac arteries by using a ¿kissing stent¿ technique.It was reported to gore that during the procedure, it was noticed that all of the implanted viabahn® vbx endoprostheses had started to occlude.Immediately, a thrombectomy was performed which was however unsuccessful.It was stated, that blood supply to the lower extremities remained in a small lumen within the three viabahn® vbx endoprostheses.Additionally, collateral vessels were supplying the lower extremities.The result of an intra-operative rapid on-demand hit blood test (hit - heparin-induced thrombocytopenia) was positive.It was reported to gore that, due to this, heparin was replaced by argatroban for anticoagulation.One week after the procedure an external elisa hit ii test was performed.The result was negative.Therefore it was decided to change back to heparin for anticoagulation.Computertomographic angiography (cta) control imaging, performed one week after the procedure, demonstrated a significant reduction of the thrombus mass.All three viabahn vbx devices were patent.It was reported to gore that, for the time being, this outcome is considered to be satisfactory.

Manufacturer Narrative

Event (b)(4).In total three reports were submitted for the notified medical incident with the following lot numbers: lot #20147654; udi #(b)(4); mfr report #2017233-2019-00233; lot #20147806; udi #(b)(4); mfr report #2017233-2019-00234; lot #20175807; udi #(b)(4); mfr report #2017233-2019-00235.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8508536
• MDR Text Key: 141739634
• Report Number: 2017233-2019-00233
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2021
• Device Catalogue Number: BXAL085902E
• Device Lot Number: 20147654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR