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

Catalog Number	PXB35-10-37-080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: two cine images were received with the initial reported event.The images are of two stent stents in the superior vena cava with a guidewire running through one of the stents.The stents appear to be in two different branches of the vena cava.In the second image the stent with the guidewire appears to be in the foreground of the second stent.The two cine images do not show the non-deployed visi-pro stent dislodged within the 7fr sheath.The visi-pro balloon-expandable stent system was also received for evaluation.The visi-pro stent was received loose within the shelf carton and not attached to the visi-pro delivery system.The stent appeared bent, stretched, one end is longitudinally compressed, and one strut radiopaque marker hoop on the other end of the stent is bent outward.The visi-pro balloon chamber exhibited witness marks of a crimped stent and was in a pre-inflation profile, (e.G.Tightly wrapped and winged).Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a visi-pro balloon expandable stent to treat a slightly tortuous 60 mm mid-left superior vena cava (svc) lesion.The device was removed from its packaging and inspected with no issues noted.It was reported that the stent was prepped per the ifu and a non-mdt guidewire was used.Embolic protection was not used.It was reported that two ¿kissing stents¿ were deployed in the svc one day prior to this procedure - a protege 12 x 60 self-expanding stent from the left svc and a 9x60 protege self-expanding stent from the right svc.The 12x60 protege stent was reportedly occluded due to the formation of a clot.It was reported that physician decided to use a visi-pro balloon-expandable stent to keep the vessel open.The visi-pro stent was unable to cross through the previously deployed 12x60 protege stent.Upon attempting to remove this stent, difficulty was experienced causing the stent to come off the balloon inside the 7 fr sheath.The physician was successful in removing the sheath and the dislodged stent together.The physician then used another visi-pro balloon expandable stent to complete the procedure.No patient injury was 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: 6837223
• Report Number: 2183870-2017-00365
• Device Sequence Number: 13671271
• Product Code: FGE
• UDI-Device Identifier: 00821684036662
• UDI-Public: 00821684036662
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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: 11/01/2019
• Device Catalogue Number: PXB35-10-37-080
• Device Lot Number: A368928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR