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

Model Number	26926
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that partial stent deployment occurred.A 6x150x130 innova self-expanding stent was selected for a procedure in the heavily calcified superficial femoral artery (sfa).The lesion had minimal tortuosity and pre-dilation was performed with no yielding of the calcium.A contralateral approach was used to access the lesion.During deployment, the stent stopped deploying after 5cm.There was some difficulty removing the stent.The entire delivery system and stent were able to be pulled back into the sheath and removed.The procedure was completed without any stent being used and there were no patient complications.
Event or Problem Description
It was reported that partial stent deployment occurred.A 6x150x130 innova self-expanding stent was selected for a procedure in the heavily calcified superficial femoral artery (sfa).The lesion had minimal tortuosity and pre-dilation was performed with no yielding of the calcium.A contralateral approach was used to access the lesion.During deployment, the stent stopped deploying after 5cm.There was some difficulty removing the stent.The entire delivery system and stent were able to be pulled back into the sheath and removed.The procedure was completed without any stent being used and there were no patient complications.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent system with a.035" guidewire stuck inside.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed buckling to the outer sheath at 37.3cm, 39.9cm, and 40.1cm from the nosecone.There are multiple kinks along the inner liner that is exposed.There is a kink to the outer sheath at the nosecone.There is buckling to the proximal inner where the clip is located.The middle sheath appears to have been pulled out of the retainer.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device, revealed no other damage or irregularities.

• 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: 9824530
• Report Number: 2134265-2020-02922
• Device Sequence Number: 16915658
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2022
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0024020807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1