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

Model Number	26924
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was difficult to track over the wire and inadvertently deployed.A 6 x 60 x 130 innova self-expanding stent was selected for a procedure.Upon inserting the stent delivery system over the.014 wire, it was difficult to track over the wire.Prior to entering the sheath, the physician noticed the stent had flowered out.The procedure was completed successfully with a new 6 x 60 innova device and patient was reported as fine post procedure.
Additional Manufacturer Narrative
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 1.5cm 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 yellow thumbwheel lock is missing.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the stent was difficult to track over the wire and inadvertently deployed.A 6x60x130 innova self-expanding stent was selected for a procedure.Upon inserting the stent delivery system over the.014 wire, it was difficult to track.Prior to entering the sheath, the physician noticed the stent had flowered out.The procedure was completed successfully with a new 6x60 innova device and patient was reported as fine post procedure.

• 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: 10493891
• Report Number: 2134265-2020-12306
• Device Sequence Number: 2476874
• Product Code: NIP
• UDI-Device Identifier: 08714729874003
• UDI-Public: 08714729874003
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 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: 09/02/2022
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0024369734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 09/25/2020
• Patient Sequence Number: 1