MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; STENT, ILIAC

Model Number	PXB35-06-27-135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image review: a single photograph of a procedural image was provided for analysis.No procedural devices were received for analysis.The image is a side profile cine.In the image the visi-pro stent appears to be fractured into two segments.Due to the quality and clarity it is not possible to visualize individual stent strut rows.One segment appears longer than the other of the unknown length stent.Given that the targeted lesion length is 30mm the stent is most likely a 27mm length stent.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician implanted a visipro balloon expandable stent during procedure to treat a moderately calcified plaque lesion in the mid biliary artery of superior mesenteric artery (sma) with 90+% stenosis.The vessel was moderately calcified.The vessel diameter and lesion length were 6mm and 30mm respectively.Non-medtronic 6fr sheath and 0.035" guidewire were used during procedure.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.The lesion was not pre dilated.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.Post angiography revealed brisk flow with the stent fully inflated.Post procedure, there was no identified issues with the visipro.When the patient was seen for a follow up appointment, the visipro stent fracture was noted on the mri.There was no vessel damage noted.There was no other stent present in the sma besides the visipro.The stent was not removed and a non-medtronic stent was placed.Patient is doing well and seen at follow-up.Imaging shows stent fractured in half.There are no plans to remove the fractured stent.No further injury reported.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 11363951
• Report Number: 2183870-2021-00074
• Device Sequence Number: 792926
• Product Code: NIO
• UDI-Device Identifier: 00643169787698
• UDI-Public: 00643169787698
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: PXB35-06-27-135
• Device Catalogue Number: PXB35-06-27-135
• Device Lot Number: B091412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/23/2021
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 119