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

Model Number	26924
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent foreshortened.A 7x40x130 innova self expanding stent was selected to treat a lesion during a peripheral angioplasty procedure.Once the stent was deployed it was observed that the stent dramatically foreshortened on the proximal end.Additional stenting was required to fully cover the lesion.The procedure was completed without further complications and the patient recovered and was discharged.
Event or Problem Description
It was reported that the stent foreshortened.A 7x40x130 innova self expanding stent was selected to treat a lesion during a peripheral angioplasty procedure.Once the stent was deployed it was observed that the stent dramatically foreshortened on the proximal end.Additional stenting was required to fully cover the lesion.The procedure was completed without further complications and the patient recovered and was discharged.Additional information reported that there was no difficulty in the deployment.The stent shortened 1/2 cm.The lesion was 98% stenosed in the highly calcified mid superficial femoral artery (sfa).The lesion was pre-dilated.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8403877
• Report Number: 2134265-2019-01916
• Device Sequence Number: 11260181
• Product Code: NIP
• UDI-Device Identifier: 08714729874089
• UDI-Public: 08714729874089
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• 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
• Report Date (Section B): 03/25/2019

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: 10/11/2021
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 22781417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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