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

Model Number	26924
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: (b)(6).
Event or Problem Description
It was reported that the stent prematurely deployed.A 6x40x130 innova self-expanding stent was selected for use in the left leg.During the procedure, they were advancing the stent on the wire over the iliac in normal, non-tortuous anatomy when the stent began to deploy.The lock was still in place.The device was able to be retrieved successfully without full deployment of the stent.A new stent was used to complete the case.There were no patient complications and patient was reported as doing good post procedure.
Additional Manufacturer Narrative
A2: age at time of event - over 60 years.Device evaluated by manufacturer: the device was returned for analysis.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.Microscopic examination revealed no additional damages.The stent was missing.The thumbwheel lock was missing.The rack had moved 7mm from the handle to the knob.The middle sheath was no longer sitting on top of the proximal tip.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the stent prematurely deployed.A 6x40x130 innova self-expanding stent was selected for use in the left leg.During the procedure, they were advancing the stent on the wire over the iliac in normal, non-tortuous anatomy when the stent began to deploy.The lock was still in place.The device was able to be retrieved successfully without full deployment of the stent.A new stent was used to complete the case.There were no patient complications and patient was reported as doing good 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: 9962436
• Report Number: 2134265-2020-05091
• Device Sequence Number: 16895885
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/08/2020

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: 07/02/2022
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0024048487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/08/2020
• Patient Sequence Number: 1