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

Model Number	H74939293061870
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The 90% stenosed target lesion was located in a mildly tortuous and moderately calcified superficial femoral artery (sfa).Ipsilateral antegrade approach was performed.Following pre-dilation, a 6x180x75 innova stent was placed and deployment was initiated via the thumb wheel.During deployment the stent stretched about 2cm on the proximal side.The physician states that he felt tension on the shaft at the time of the event.After deploying 120mm of the stent, the deployment stopped, the physician continued to turn the thumbwheel and deployment was eventually achieved.The procedure was completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds).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.There was kink noticed on the inner shaft at the distal end of the mid-shaft.The stent was not returned.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 cause of the reported difficulties could not be determined.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The 90% stenosed target lesion was located in a mildly tortuous and moderately calcified superficial femoral artery (sfa).Ipsilateral antegrade approach was performed.Following pre-dilation, a 6x180x75 innova¿ stent was placed and deployment was initiated via the thumb wheel.During deployment the stent stretched about 2cm on the proximal side.The physician states that he felt tension on the shaft at the time of the event.After deploying 120mm of the stent, the deployment stopped, the physician continued to turn the thumbwheel and deployment was eventually achieved.The procedure was completed with this device.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: 6709032
• Report Number: 2134265-2017-06867
• Device Sequence Number: 13845514
• Product Code: NIP
• UDI-Device Identifier: 08714729873693
• UDI-Public: (01)08714729873693(17)20190731(10)19438864
• Combination Product (Y/N): N
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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: 07/31/2019
• Device Model Number: H74939293061870
• Device Catalogue Number: 39293-06187
• Device Lot Number: 19438864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1