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

Model Number	26928
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed.A 5x100x130mm innova vascular stent was selected for use for a subclavian graft bypass procedure in the leg.The target lesion did not have much tortuosity, had no calcification, and no stenosis was observed, however, the target lesion was thrombosed.Following pre-dilation, the innova stent was advanced over a.018 guidewire and deployment initiated.The stent only began to flower from the deployment system when the thumbwheel began to spin freely without the stent deploying any further.The pull grip was then attempted and again the stent did not deploy.The physician also attempted to break open the handle to see if the stent could be deployed, but this was unsuccessful.The physician also attempted to switch out the guidewire for a.035 size and that was also unsuccessful.The physician then inserted a larger and longer sheath and was able to withdraw the stent into the sheath and remove the stent and delivery system together.There were no patient complications and the patient's status post procedure was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the outer sheath, tip, inner sheath and the remainder of the device were checked for damage.The device returned in several broken pieces.The handle was opened and the opaque clip on the handle was missing.The yellow thumbwheel protector returned with the device but was not attached or covering the thumbwheel.The stent was returned but was stuck inside the introducer sheath.An x-ray of the introducer sheath showed that the stent was stretched.The rack is broken 24.4cm from the proximal end of the pull grip.The first teeth on the rack was damaged.There was damage to the last teeth on the distal section of the rack before the separation.Multiple flat spots were noted on the teeth in the middle of the thumbwheel.The outer sheath was separated at the nosecone and appeared to have snapped.From the tip to the separated middle sheath was approximately 128.4cm long.There was multiple buckling to the middle sheath and outer sheath combined.There were pieces of the proximal inner and inner liner that were separated.The separated inner liner was approximately 10.5cm and 11.1cm long.The separated proximal liner was approximately 12.9cm and 11.1cm long.There were multiple tears on the middle sheath that were longitudinal and circumferential in shape.Further analysis did not find any marks within the handle that are common signs of prolapsing, which would cause partial or deployment issues.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the stent partially deployed.A 5x100x130mm innova vascular stent was selected for use for a subclavian graft bypass procedure in the leg.The target lesion did not have much tortuosity, had no calcification, and no stenosis was observed, however, the target lesion was thrombosed.Following pre-dilation, the innova stent was advanced over a.018 guidewire and deployment initiated.The stent only began to flower from the deployment system when the thumbwheel began to spin freely without the stent deploying any further.The pull grip was then attempted and again the stent did not deploy.The physician also attempted to break open the handle to see if the stent could be deployed, but this was unsuccessful.The physician also attempted to switch out the guidewire for a.035 size and that was also unsuccessful.The physician then inserted a larger and longer sheath and was able to withdraw the stent into the sheath and remove the stent and delivery system together.There were no patient complications and the patient's status post procedure was fine.

• 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: 8152384
• Report Number: 2134265-2018-63713
• Device Sequence Number: 19227996
• Product Code: NIP
• UDI-Device Identifier: 08714729873938
• UDI-Public: 08714729873938
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 06/30/2019
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0019372768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR DESTINATION SHEATH; 6FR DESTINATION SHEATH
• Patient Age: 70 YR