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

Catalog Number	PXB35-06-27-135
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/23/2019
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
It was reported that the physician intended to use a visipro stent to treat a moderately calcified, moderately tortuous lesion in the mid right common iliac artery.The lesion was not pre-dilated.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped without issue.A 6fr non-medtronic sheath and a 0.035¿ non-medtronic glide wire were used for the procedure.There was no embolic protection used.The device did not pass through a previously deployed stent however, resistance was encountered but no excessive force was applied during advancement of the device to the lesion.It was reported that as the stent was being delivered to the target lesion, it became stuck on an area of calcium.When the physician pulled back to reposition the stent, it dislodged at the lesion.2 evercross balloons -a 3x40, a 6x40 ¿ were used to fully deploy the stent.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information: the stent dislodged at the target lesion site and was deployed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: the visipro balloon device was returned with the balloon in its pre inflation profile.The balloon expandable stent was not returned.There was no indication the balloon was inflated due to evidence of crimp marks observed in the location the stent was previously loaded.No abnormalities or deformities were observed on the catheter shaft and distal tip.A 0.035in compatible guidewire from analysis lab as loaded through the distal tip of the visi-pro and was able to navigate the full length of the visi-pro with ease.The guidewire loaded stent delivery system was advanced into a 6f sheath.If information is provided in the future, a supplemental report will be issued.

• 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: 8548814
• Report Number: 2183870-2019-00183
• Device Sequence Number: 13530915
• Product Code: NIO
• UDI-Device Identifier: 00643169787698
• UDI-Public: 00643169787698
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 08/01/2019

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: 10/16/2021
• Device Catalogue Number: PXB35-06-27-135
• Device Lot Number: A724936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/29/2019; 07/31/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/21/2019; 08/01/2019
• 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: 75 YR