MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PXB35-06-57-080
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the visi-pro was inspected and found no damages to the catheter shaft or manifold.The stent was loaded on the balloon segment and inspected under microscope.Clear fibers were observed sticking out from the stent segment.The fibers were consistent with the appearance of being wiped down with a cloth.The stent was secured on the balloon.The distal end of the stent showed a portion protruding outward.It was discovered one of the tantalum spheres of the stent was bent and crossed under one of the stent struts.Functional testing: a 0.035" guidewire was front-loaded the catheter.The balloon port of the manifold was connected to a lab inflation device filled with water.Pressure was applied and it was noted at approximately 2 atm the distal and proximal ends of the stent started to expand.At 4 atm the balloon was inflated and the stent was expanded.The stent was able to be removed from the balloon.Traces of dried blood was noted at the distal and proximal ends of the stent.The tantalum sphere remained bent under one of the struts, but the entire stent expanded as intended.
Event or Problem Description
Physician was using a visipro ballon-expandable stent to treat a lesion.It was reported that the stent would not deploy.The hcp is of the opinion the stent was crimped on too tight.There were no interventions required or patient injury reported.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7001043
• Report Number: 2183870-2017-00479
• Device Sequence Number: 16439461
• Product Code: FGE
• UDI-Device Identifier: 00821684036358
• UDI-Public: 00821684036358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2018
• Device Catalogue Number: PXB35-06-57-080
• Device Lot Number: A198553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1