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

Model Number	H74939293071530
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the stent was shorter than expected once deployed.Vascular access was obtained via the popliteal.The 100% stenosed target lesion was located in the minor tortuous and moderately calcified distal superficial femoral artery (sfa).Following post-dilation, a 7x150x130 innova¿ stent was advanced and deployed without issues.After deployment, it appeared the stent was only 100mm in length.A 6x150 balloon catheter was placed across the stent and it was noted that the balloon was 4-5cm longer than the stent.A 7x80x130 innova¿ stent was deployed in normal fashion with appropriate overlap of the first stent placed, followed by post dilataion.The procedure was completed successfully with good distal run off and full stent expansion.There were no patient complications reported.
Additional Manufacturer Narrative
Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.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 other damage was noticed on the shafts.The thumbwheel turned freely.The stent was not returned so the shorting of the stent could not be confirmed.The handle was opened to inspect for additional damage, no damage was noticed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported stent length issue, which could not be confirmed because the clinical circumstances could not be replicated.The applicable manufacturing records related to the complaint device were reviewed.It was confirmed that the devices in this batch met all applicable specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
Event or Problem Description
It was reported that the stent was shorter than expected once deployed.Vascular access was obtained via the popliteal.The 100% stenosed target lesion was located in the minor tortuous and moderately calcified distal superficial femoral artery (sfa).Following post-dilation, a 7x150x130 innova¿ stent was advanced and deployed without issues.After deployment, it appeared the stent was only 100mm in length.A 6x150 balloon catheter was placed across the stent and it was noted that the balloon was 4-5cm longer than the stent.A 7x80x130 innova¿ stent was deployed in normal fashion with appropriate overlap of the first stent placed, followed by post dilataion.The procedure was completed successfully with good distal run off and full stent expansion.There were no patient complications 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: 7360020
• Report Number: 2134265-2018-02190
• Device Sequence Number: 19411291
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: H74939293071530
• Device Catalogue Number: 39293-07153
• Device Lot Number: 20442150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHARGER 6X150 BALLOON CATHETER; CHOCOLATE BALLOON CATHETER
• Outcome Attributed to Adverse Event: Required Intervention