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

Catalog Number	PXB35-08-37-135
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation the visipro was inspected and found traces of dried blood to the exterior of the device.The stent remained loaded over the balloon and showed no signs of expansion.The distal edge of the loaded stent was approximately 1cm from the distal tip of the catheter shaft.A bend to the stent was noted at approximately 3cm from the distal rim of the stent.The distal and proximal ends of the loaded stent were inspected under microscope.The proximal end of the stent appeared to show partial expansion.The stent was attempted to be pulled off by hand, but the stent remained loaded over the balloon.A 0.035" gw was loaded approximately 20 cm from the distal tip before encountering a blockage.The blockage was likely dried biological material and/or dried contrast.The visipro was able to be loaded through the 6f sheath from the lab.Upon attempted withdrawal, the proximal end of the stent caught up on the distal rim of the sheath.The stent had to be removed in order to withdraw the catheter from the introducer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a visi pro balloon expandable stent with a 6fr sheath and non-medtronic guidewire during treatment of a calcified lesion in the patient¿s proximal right common iliac artery of diameter 8mm.Slight tortuosity and severe calcification are reported.Lesion exhibited 90% stenosis.Ifu was followed and the device was prepped without issue.Pre-dilation was not performed.Moderate resistance was experienced and the device would not be advanced through the lesion.The visi pro was removed.When removed, an evercross balloon was used to pre-dilate the lesion with success.The visi pro was then re-introduced the visi pro was then re-introduced but the stent was observed to have come loose on the balloon while advancing through the sheath, while outside the body, and physician decided to remove the entire system.The stent appeared to have become hung up on the cross-cut valve of the non-medtronic sheath.The entire system was removed and replaced with a new visi pro to complete the procedure.No injury reported.When the device was returned to the manufacturing faculty for evaluation, it was noticed that the device was damaged.

• 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: 9537797
• Report Number: 2183870-2020-00002
• Device Sequence Number: 2299922
• Product Code: FGE
• UDI-Device Identifier: 00643169787889
• UDI-Public: 00643169787889
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

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: 06/12/2022
• Device Catalogue Number: PXB35-08-37-135
• Device Lot Number: A847507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR