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

Catalog Number UNK-PLY-VISIPRO

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Rupture (2208); Patient Problem/Medical Problem (2688)

Event Date 06/09/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician intended to use a visipro be stent to treat a lesion in the proximal superficial femoral/common femoral artery.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped per ifu without issue.The device did not pass through a previously deployed stent.It was reported that the physician tried to deliver the stent to the contralateral side without a long contralateral sheath.The stent dislodged at the common iliac bifurcation.He then attempted, unsuccessfully, to retrieve the stent with a snare.He had to pull the stent with the snare and the sheath leading to bleeding at the access site and damage to the artery.The procedure was aborted and the patient taken to the op.Patient is reported to be alive with injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8703850
• MDR Text Key: 148163936
• Report Number: 2183870-2019-00338
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-PLY-VISIPRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention