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

Catalog Number	PXB35-05-27-135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Visipro stent was implanted in the superior mesenteric artery.It was reported that stent fracture occurred a few months after deployment.Patient complained of abdominal pain and was re-imaged to find the original stent in two pieces.No further patient injury was reported for this event.
Additional Manufacturer Narrative
Implanted date: month and year valid additional information: the visipro stent was used to treat a proximal superior mesenteric artery stenosis which was visualized by angiography and ivus.Lesion exhibited 90% stenosis.The vessel was cannulated, with some difficulty due to vessel angulation, using a 5fr angled catheter.A non-medtronic guidewire was inserted and the stenosis was pre-dilated using a 3mm pta balloon catheter.A visipro balloon expandable stent was placed without difficulty across the lesion.The stent balloon was inflated to 8atm.The stent delivery system was removed without complication.A follow-up angiogram was performed, and the stent was intact and did not appear to need post dilatation and showed satisfactory resolution of the stenosis.An ivus catheter was inserted to determine stent apposition.No further stent dilatation was needed.All catheters and the sheath were removed without complication.The site was dressed, and pressure dressing was applied.The patient recovered fully in the pacu in stable condition and discharged the next day without complication.The stent fracture was observed approximately 4 months post procedure.Patient had a repeat stenting procedure carried out 2.5 weeks post fracture identification.A visi pro stent was placed in the proximal superior mesenteric artery to cover the fractured area.Procedure was successful, patient has been discharged without complication.If information is provided in the future, a supplemental report will be issued.

• 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: 9480456
• Report Number: 2183870-2019-00592
• Device Sequence Number: 258953
• Product Code: FGE
• UDI-Device Identifier: 00643169787605
• UDI-Public: 00643169787605
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2022
• Device Catalogue Number: PXB35-05-27-135
• Device Lot Number: A853923
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Weight: 48