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	12/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 50's.(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 stent foreshortening occurred.The target lesion was located in the right superficial femoral artery (sfa) that measured 142mm in length.Pre-dilation was performed with a 5x120 non-bsc balloon catheter, followed by the advancement of a 7 x 150 x 130 innova¿ stent over a v18 guidewire via an antegrade approach.The stent was deployed without any noted difficulties; however upon deployment the stent was severely foreshortened leaving a portion of the lesion uncovered.The deployed stent measured approximately 115mm.Additional stenting with a 7x60 non-bsc stent was required to cover the remaining lesion.No patient complications were reported and the patient's condition is fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: an innova self-expanding stent delivery system (sds) was returned for analysis and the outer shaft and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.The outer sheath also showed some buckling and twisting.No damage was noticed on the mid-shaft.There was a kink on the inner liner at 6cm from the markerband.The blue pull rack was completely broken off from the handle.The stent was not returned in the device.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 was unable to be determined.(b)(4).
Event or Problem Description
It was reported that stent foreshortening occurred.The target lesion was located in the right superficial femoral artery (sfa) that measured 142mm in length.Pre-dilation was performed with a 5x120 non-bsc balloon catheter, followed by the advancement of a 7 x 150 x 130 innova stent over a v18 guidewire via an antegrade approach.The stent was deployed without any noted difficulties; however upon deployment the stent was severely foreshortened leaving a portion of the lesion uncovered.The deployed stent measured approximately 115mm.Additional stenting with a 7x60 non-bsc stent was required to cover the remaining lesion.No patient complications were reported and the patient's condition is 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: 7140051
• Report Number: 2134265-2017-12749
• Device Sequence Number: 18853455
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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: 10/04/2020
• Device Model Number: H74939293071530
• Device Catalogue Number: 39293-07153
• Device Lot Number: 0021216867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention