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

Catalog Number PXP35-07-37-135

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/11/2019

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 slightly calcified, moderately tortuous, plaque lesion in the mid left common iliac artery.The artery diameter and the lesion length were reported to be 7 mm and 30 mm, respectively.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.There was no embolic protection used for the procedure.The lesion was crossed by a guidewire from the left common femoral artery.While progressing the stent on the guidewire, the stent dislodged from its balloon in the left common iliac, before the balloon was inflated.It was removed by removing the guidewire but there was difficulty experienced at the common femoral artery.A forceps was then used to remove the stent but while doing that the stent broke into pieces.Half of the stent was removed while the other half remained in the patient.Atherectomy was then performed to remove the remaining stent.The procedure was complete d using ipsilateral approach(from the right common femoral artery) and a visipro 7x57 was deployed in the right common iliac artery.

Manufacturer Narrative

Additional information: lesion described as plaque lesion with 90% stenosis in the mid right common iliac artery.Arteriotomy was performed to remove the remaining portions of the stent.All device components were removed from the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the visi-pro device was retuned.No ancillary devices were included.The visi-pro was inspected and observed the stent was not loaded the balloon.Fragments of the stent were enclosed a separate pouch within the returned packaging.The catheter/deployment system was inspected, and the balloon appeared expanded; however, witness marks from the stent previously being loaded was identified.No damages to the catheter and/or balloon segment were noted.The fragments in the pouch of the stent were analyzed.Two pieces of the stent were identified.Tissue was observed between the stent struts.The stent was soaked in water and then attempted to remove the adhered tissue with a needle nose tweezers.It was discovered the stent was fractured into four pieces.One end of the stent which included the tantalum markers.The other end of the stent which included the other tantalum markers could not be identified from the returned fragments of the stent.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: 8703167
• MDR Text Key: 148149013
• Report Number: 2183870-2019-00337
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P030045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2019

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 Expiration Date: 10/05/2021
• Device Catalogue Number: PXP35-07-37-135
• Device Lot Number: A719511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2018
• 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
• Patient Age: 62 YR
• Patient Weight: 66