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

Catalog Number	PXB35-05-27-135
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/18/2019
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 'messenger occlusion'.The device was prepped with no issues identified.The lesion was not pre-dilated.The device did not pass through a previously deployed stent, no resistance was encountered when advancing the device and no excessive force was used.It was reported that while delivering the stent to the lesion, a stent dislodgement occurred.The patient was taken to surgery to have the stent explanted.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received from medwatch (b)(4) a balloon mounted stent fell off its balloon inside this patient at a non-intended location.This was due to a tortuous complex vascular anatomy.It was reported that although it would help to prevent stents from falling off the balloon due to stress during device navigation, the physician did not feel it was safe to insert a long sheath with a tip near the intend site of balloon mounted stent deployment as the patient had a difficult arch anatomy and a native brachial artery which was nearly occluded by the 6fr brachial sheath used in this procedure.The patient complained of intra-procedural hand numbness because of the decrease arterial supply to her hand.This was observed during angiography.It was felt that placement of a long sheath into the descending aorta could have occluded more of the upper extremity and would putting the arm at risk for severe ischemia or thrombosis and or cause a stroke by obstruction of the left vertebral artery.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: target vessel was the superior mesenteric artery (sma).The stent dislodged before deployment.There was no evidence of a balloon burst.The device was removed from the patient intact.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: 8280849
• Report Number: 2183870-2019-00036
• Device Sequence Number: 1259699
• Product Code: NIO
• UDI-Device Identifier: 00821684036235
• UDI-Public: 00821684036235
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2019

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: 04/22/2021
• Device Catalogue Number: PXB35-05-27-135
• Device Lot Number: A634321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/29/2019; 02/08/2019; 04/09/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/15/2019; 02/22/2019; 04/10/2019
• 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: 78 YR