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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDO; ILIAC COVERED STENT, ARTERIAL
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W. L. GORE ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDO; ILIAC COVERED STENT, ARTERIAL Back to Search Results
Model Number BXA085901A
Device Problem Failure to Deflate (4060)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/07/2020
Event Type  malfunction  
Event Description
Vascular surgery was performing a balloon inflation to left iliac artery.During attempt to deflate balloon the contrast would not come back into indeflator.Attempted to use a new indeflator and syringes; without success.Surgeon attempted for an hour to deflate balloon without success.No kinks seen in line under fluoroscopy.Another vascular surgeon came to assist, and the surgeons were to use a wire to pop balloon to get it deflated.Extended time on table for patient.
 
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Brand Name
GORE VIABAHN VBX BALLOON EXPANDABLE ENDO
Type of Device
ILIAC COVERED STENT, ARTERIAL
Manufacturer (Section D)
W. L. GORE ASSOCIATES, INC.
1505 north fourth st
flagstaff AZ 86004
MDR Report Key10612525
MDR Text Key209363279
Report Number10612525
Device Sequence Number1
Product Code PRL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberBXA085901A
Device Catalogue NumberBXA085901A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2020
Date Report to Manufacturer10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age24455 DA
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