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

Model Number	H74939293052030
Medical Device Problem Codes	Stretched (1601); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that partial stent deployment and stent damage occurred.The 80% stenosed target lesion was located in the moderately calcified superficial femoral artery (sfa).The lesion was pre-dilated with a 3mm coyote balloon catheter.A 5x200x130 innova was selected and advanced over a.035' non bsc guidewire via a contralateral approach to the target lesion.The physician noticed a drag while advancing the delivery system.Deployment was initiated and the stent deployed 190mm.The last 10mm would not deploy from the delivery system.Eventually the stent was fully deployed by the physician performing a gentle tug of the delivery system.It was observed that the last 10mm of the stent was stretched.An additional 150mm innova stent was used to cover the stretched portion of the stent.No patient complications were reported and the patient's status is fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: an innova self-expanding stent delivery system (sds) was returned and the outer shaft, mid-shaft and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.The mid-shaft showed no damage.The inner liner showed a kink approximately 18.5cm from the tip.The handle was opened for inspection for further damage no additional damage was noticed.The stent damage could not be confirmed due to the stent not being returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that partial stent deployment and stent damage occurred.The 80% stenosed target lesion was located in the moderately calcified superficial femoral artery (sfa).The lesion was pre-dilated with a 3mm coyote balloon catheter.A 5x200x130 innova¿ was selected and advanced over a.035' non bsc guidewire via a contralateral approach to the target lesion.The physician noticed a drag while advancing the delivery system.Deployment was initiated and the stent deployed 190mm.The last 10mm would not deploy from the delivery system.Eventually the stent was fully deployed by the physician performing a gentle tug of the delivery system.It was observed that the last 10mm of the stent was stretched.An additional 150mm innova stent was used to cover the stretched portion of the stent.No patient complications were reported and the patient's status 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: 6912955
• Report Number: 2134265-2017-09488
• Device Sequence Number: 18863108
• Product Code: NIP
• UDI-Device Identifier: 08714729873976
• UDI-Public: 08714729873976
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/08/2017

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: 12/31/2019
• Device Model Number: H74939293052030
• Device Catalogue Number: 39293-05203
• Device Lot Number: 20112175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 10/31/2017
• 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
• Patient Age: 73 YR