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

Model Number	H74939293064030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds).The outer shaft and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.No damage was noticed on any other shafts.No damage on the tip was noticed.The stent was returned with the device; however, it was deployed.The stent showed no damage.The device was still intact with the thumbwheel lock in place and the pull handle was in the start position.No blood was noticed on the device.The stent was most likely deployed as the device was being inserted into the introducer sheath and the stent was pulled from the mid-shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 that the stent deployed prematurely.A 6x40x130 innova¿ stent was selected for an angioplasty procedure in the superficial femoral artery (sfa).During the procedure, the physician was inserting the stent over the wire and the stent deployed prematurely before putting the catheter into the sheath.The safety lock was still on.The stent and catheter were safely removed back off the wire with no additional maneuvers required.The procedure was completed with a different stent.There were no patient complications and the patient was stable post procedure.

• 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: 7177288
• Report Number: 2134265-2017-13047
• Device Sequence Number: 11250644
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• 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): 12/15/2017

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: 02/29/2020
• Device Model Number: H74939293064030
• Device Catalogue Number: 39293-06403
• Device Lot Number: 0020247013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1