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

Model Number	H74939293088030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in the left arm.A 8mm-80mm/130cm innova¿ stent was advanced to the target lesion.It seemed to be deploying fine, however, at the end of the deployment resistance was met and a piece of the stent broke off.A non-bsc stent was used to tack it down so it would not sling into the inferior vena cava.The procedure was completed.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova delivery system and no other devices.The innova stent was not returned.The outer shaft, middle shaft and the remainder of the device were checked for damage.The outer shaft was kinked and buckled at the nosecone.There also was a kink on the inner shaft at 9.5cm from the tip.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 most probable cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in the left arm.A 8mm-80mm/130cm innova¿ stent was advanced to the target lesion.It seemed to be deploying fine, however, at the end of the deployment resistance was met and a piece of the stent broke off.A non-bsc stent was used to tack it down so it would not sling into the inferior vena cava.The procedure was completed.No patient complications were reported and the patient's status was 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: 6298081
• Report Number: 2134265-2017-00415
• Device Sequence Number: 578061
• Product Code: NIP
• UDI-Device Identifier: 08714729874195
• UDI-Public: (01)08714729874195(17)20181031(10)18558410
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/12/2017

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: 10/31/2018
• Device Model Number: H74939293088030
• Device Catalogue Number: 39293-08803
• Device Lot Number: 18558410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 02/16/2017
• 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