MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Catalog Number JHJR081502J

Device Problems Inadequacy of Device Shape and/or Size (1583); Human-Device Interface Problem (2949); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu), complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to thrombosis or occlusion and migration.Migration of the endoprosthesis may require surgical intervention.Additionally, the ifu states: special care should be taken to ensure that the appropriate size endoprostheses are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.

Event Description

On (b)(6) 2018, this patient underwent an endovascular repair for a left popliteal artery aneurysm using gore® viabahn® endoprosthesis with heparin bioactive surface.After two endoprostheses (8 mm x 15 cm, 8 mm x 10 cm) were deployed, it was reported that a slight distal type i endoleak remained.Reportedly, the endoleak occurred as the length of the endoprostheses was insufficient.The physician elected to monitor it and concluded the procedure.The patient reportedly tolerated the procedure.On (b)(6) 2018, the patient experienced pain of the left leg.On (b)(6) 2018, imaging showed that the endoprostheses and below-knee region were occluded.Migration of the distal placed endoprosthesis (jhjr081502j/unk ) was also observed.Reportedly, the endoprosthesis had migrated proximally around 2-3 cm.The endoleak was not visible on that date.On the same day, re-intervention was performed.Emergent thrombectomy was done from the left superficial femoral artery to the endoprostheses, and below-knee region.A gore® viabahn® endoprosthesis with heparin bioactive surface (8 mm x 25 cm) was additionally implanted in the left popliteal artery.Plain old balloon angioplasty was performed for the below-knee region.After that, the procedure was concluded.The patient reportedly tolerated the re-intervention.The physician reported that the endoprostheses were undersize against the patient artery, and the migration may be caused by knee bending and stretching.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7393464
• MDR Text Key: 104213063
• Report Number: 2017233-2018-00202
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR081502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR