MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 26920

Device Problem Migration (4003)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/20/2019

Event Type  Injury  

Event Description

It was reported that stent migration occurred.A 6x40x75 innova stent was selected for a percutaneous transluminal angioplasty (pta) procedure in the superficial femoral artery (sfa).During the procedure, the stent migrated distally.The lesion was not fully covered as a result.The patient was required to undergo an additional procedure.There were no patient complications reported.

Event Description

It was reported that stent migration occurred.A 6x40x75 innova stent was selected for a percutaneous transluminal angioplasty (pta) procedure in the superficial femoral artery (sfa).During the procedure, the stent migrated distally.The lesion was not fully covered as a result.The patient was required to undergo an additional procedure.There were no patient complications reported.Additional information received reported that the patient's vessel diameter was 6mm, the degree of calcification was severe and the stenosis was 80%.The lesion was pre-dilated using a 5mm balloon.The additional procedure performed was the placement of an additional stent overlapping the innova stent.The physician reported that the stent migrated because when he deployed the stent, the system did not straighten.The stent migrated during deployment, about 20mm.There were no patient complications and the patient's status post procedure was good.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8491656
• MDR Text Key: 141200791
• Report Number: 2134265-2019-03542
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0021115588
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR