MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293061230
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product consisted of an innova self-expanding stent delivery system (sds).The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The outer sheath was kinked at the nosecone.There was some slight buckling on the outer sheath.No damage was noticed on the mid-shaft.The stent was returned inside the device and was partially deployed approximately 8mm from the markerband.The handle was in the start position.The yellow thumbwheel lock was intact on the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
It was reported the stent prematurely deployed in the sheath.A 6 x 120 x 130 innova¿ was selected for a procedure in the superficial femoral artery.Upon placing the device into the sheath, it would not advance.After advancing approximately a couple of millimeters, it would not move any further, so the device was retracted out of the sheath and removed from the patient.It was observed that part of the stent had started to deploy within the sheath.The procedure was completed with another of the same device.There were no patient complications and the patient was fine.

• Brand Name: INNOVA¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7100644
• Report Number: 2134265-2017-11825
• Device Sequence Number: 11130232
• Product Code: NIP
• UDI-Device Identifier: 08714729874034
• UDI-Public: 08714729874034
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 11/14/2017

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: 08/31/2019
• Device Model Number: H74939293061230
• Device Catalogue Number: 39293-06123
• Device Lot Number: 19635567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR