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

Model Number 26920

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

It was reported that the stent was shorter than the labeled size.A 6x100x130mm innova stent was selected for use for a stenting procedure in the superficial femoral artery (sfa).The target lesion was approximately 100mm long, with a vessel diameter of 5.0-5.5mm, and was highly calcified.The lesion was pre-dilated with a 5x100mm percutaneous transluminal angioplasty balloon.The physician then implanted the innova stent without any difficulties, and the stent appeared to be fully deployed under imaging.Post deployment, the physician noticed the lesion was not fully covered by the stent.The stent was measured to be only about 50mm long.All packaging and labels indicated that the stent was 6mmx100mm.The procedure was completed using a 6x80mm epic stent.There were no patient complications.

Event Description

It was reported that the stent was shorter than the labeled size.A 6x100x130mm innova stent was selected for use for a stenting procedure in the superficial femoral artery (sfa).The target lesion was approximately 100mm long, with a vessel diameter of 5.0-5.5mm, and was highly calcified.The lesion was pre-dilated with a 5x100mm percutaneous transluminal angioplasty balloon.The physician then implanted the innova stent without any difficulties, and the stent appeared to be fully deployed under imaging.Post deployment, the physician noticed the lesion was not fully covered by the stent.The stent was measured to be only about 50mm long.All packaging and labels indicated that the stent was 6mmx100mm.The procedure was completed using a 6x80mm epic stent.There were no patient complications.

Manufacturer Narrative

(b)(6).Device evaluated by mfr: the outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed buckling to the sheath at the nosecone approximately 19mm long.The rack is broken 36mm from the handle and the proximal end of the rack is missing.There is a kink to the inner liner at the distal end of the proximal liner.The stent was fully deployed and did not return with the device.There is blood present in the proximal liner, inner liner, and middle sheath.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8104459
• MDR Text Key: 128384154
• Report Number: 2134265-2018-62832
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2021
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0021930119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR