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

Model Number	26928
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: approximated to (b)(6) 2020.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 6x100x103 innova self-expanding stent was selected for use.Upon opening the package, the shaft was observed to be kinked and the stent was partially deployed from the catheter.The device was not used in the patient.No patient complications have been reported.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 6x100x103 innova self-expanding stent was selected for use.Upon opening the package, the shaft was observed to be kinked and the stent was partially deployed from the catheter.The device was not used in the patient.No patient complications have been reported.
Additional Manufacturer Narrative
B3: date of event: approximated to (b)(6)2020.Device analysis by mfr: the returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is partially deployed 3.5cm from the distal end of the middle sheath.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The pull handle and yellow thumbwheel lock is still in the manufactured position.There is blood present inside the sheath.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: 10443173
• Report Number: 2134265-2020-11531
• Device Sequence Number: 2726931
• Product Code: NIP
• UDI-Device Identifier: 08714729874027
• UDI-Public: 08714729874027
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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: 06/07/2025
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0025570237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/25/2020
• Patient Sequence Number: 1