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

Model Number	H74939293080230
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that the 8x20x130 innova¿ stent prematurely deployed prior to patient introduction.No patient complications were reported.
Additional Manufacturer Narrative
Device lot number initially reported as 20832033 corrected to lot number 0019064047.Device expiration date initially reported as 01/13/2019 corrected to device expiration date 03/31/2019.Device manufactured date initially reported as 06/29/2017 corrected to device manufactured date 03/22/2016.Device evaluated by mfr: 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.There was a kink at the nosecone.The stent was returned outside of the device.No other damage was noticed on the outside of the device.The thumbwheel lock was returned on the device.The pull rack was in the start position.The thumbwheel on the handle was rotated and the device functioned as designed.Since the stent returned outside of the device and was not damaged the inadvertent deployment was confirmed.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 8x20x130 innova¿ stent prematurely deployed prior to patient introduction.No patient complications were reported.

• 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: 6904134
• Report Number: 2134265-2017-09429
• Device Sequence Number: 1443941
• Product Code: NIP
• UDI-Device Identifier: 08714729874164
• UDI-Public: 08714729874164
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2017

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: 03/31/2019
• Device Model Number: H74939293080230
• Device Catalogue Number: 39293-08023
• Device Lot Number: 0019064047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1