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); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent partially deployed and the stent stretched in the patient's anatomy.The 100% stenosed target lesion was located in the moderately calcified lesion superficial femoral artery (sfa).A contralateral approach was used to access the lesion.Pre-dilation was performed.A 7x150x130 innova self-expanding stent was selected for use over.014/300 cm non-bsc guidewire.When the physician attempted to deploy the stent, it was unable to be fully deployed using the thumbwheel despite using much force.The pull grip was attempted to be used.The catheter was pulled back and the stent became stretched into the external iliac artery.A sheath dilator was used to push the deployment catheter out with the stent remaining implanted and stretched within the anatomy.The stent was not able to be removed.There were no immediate patient complications.However, the stent now sits across the common femoral artery (cfa), an area that bends and should not be stented.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of an innova self-expanding stent system with a.014" guidewire stuck inside.The stent was implanted and did not return for product analysis.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the rack is separated 10.7cm from the retainer.The proximal section of the rack is missing.There is multiple buckling to the outer sheath and middle sheath.There is a kink to the outer sheath at the nosecone.The proximal inner is prolapsed.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the stent partially deployed and the stent stretched in the patient's anatomy.The 100% stenosed target lesion was located in the moderately calcified lesion superficial femoral artery (sfa).A contralateral approach was used to access the lesion.Pre-dilation was performed.A 7x150x130 innova self-expanding stent was selected for use over.014/300 cm non-bsc guidewire.When the physician attempted to deploy the stent, it was unable to be fully deployed using the thumbwheel despite using much force.The pull grip was attempted to be used.The catheter was pulled back and the stent became stretched into the external iliac artery.A sheath dilator was used to push the deployment catheter out with the stent remaining implanted and stretched within the anatomy.The stent was not able to be removed.There were no immediate patient complications.However, the stent now sits across the common femoral artery (cfa), an area that bends and should not be stented.

• 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: 9898137
• Report Number: 2134265-2020-04016
• Device Sequence Number: 16748015
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 01/13/2025
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0025041206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT SPARTACORE, .014/300 CM; ABBOTT SPARTACORE, .014/300 CM; COOK FLEXOR 7FR/45 CM; COOK FLEXOR 7FR/45 CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR