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

Model Number	26926
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the stent prematurely deployed and upon removal it was caught on the y connector and became stretched and ultimately separated.The 99% stenosed, target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).Following pre-dilation, a 6 x 150 x 75 innova stent was advanced ipsilateral over a.035 radiofocus stiff guidewire.When the device was advanced to the severely calcified lesion there was severe resistance felt with the delivery system.The middle sheath got shifted back and the tip part of the stent became slightly deployed.During removal, the stent became caught on the y connector, stretched, and separated.The system was removed together, and the entire stent was able to be retrieved.There were no patient complications and the procedure was completed with a different device.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of an innova self-expanding stent system with the yellow thumbwheel protector still in the manufactured position.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was partially deployed and approximately 45mm is sticking out distal of the middle sheath.The section of the stent that is sticking out of the middle sheath is stretched/deformed with a separated distal section missing.The distal section of the separated stent did not return for analysis.There is approximately 90mm of the stent still in the middle sheath.Microscopic examination revealed no damages.There was blood in the middle sheath.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that the stent is partially deployed, damaged, and is missing the separated distal section.
Event or Problem Description
It was reported that the stent prematurely deployed and upon removal it was caught on the y connector and became stretched and ultimately separated.The 99% stenosed, target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).Following pre-dilation, a 6 x 150 x 75 innova stent was advanced ipsilateral over a.035 radiofocus stiff guidewire.When the device was advanced to the severely calcified lesion there was severe resistance felt with the delivery system.The middle sheath got shifted back and the tip part of the stent became slightly deployed.During removal, the stent became caught on the y connector, stretched, and separated.The system was removed together, and the entire stent was able to be retrieved.There were no patient complications and the procedure was completed with a different device.

• 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: 8675189
• Report Number: 2134265-2019-06483
• Device Sequence Number: 16952968
• Product Code: NIP
• UDI-Device Identifier: 08714729873686
• UDI-Public: 08714729873686
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 06/13/2021
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0022250221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1