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

Model Number	H74939293062030
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	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device was not returned for evaluation.Lot number was not provided therefore a ship history of previous lots sent to the customer was reviewed, dhr found no issues.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
It was reported that partial deployment and stent elongation occurred.The long, diffuse, chronic total occlusion (cto) lesion was located in the left superficial femoral artery (sfa).The lesion was from the origin of the sfa all the way to the popliteal and below that to the trifurcation.A 6 x 200 x 130 innova¿ stent was advanced contralateral over an unknown guidewire and stent deployment was initiated from the popliteal coming back up the sfa.At some point, there was an issue with deployment.The physician was not sure if the stent stopped deploying or he pulled back on the pull grip too soon.The stent was deployed completely but was stretched all the way into the external iliac and the integrity of the stent was compromised.Four additional stents were placed from the beginning to the end of the stretched stent.There was a good result for the patient with no additional complications.The procedure was completed and the patient¿s status was reported as fine post procedure.

• 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: 6980915
• Report Number: 2134265-2017-10413
• Device Sequence Number: 648834
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: 08714729874065
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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 Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/26/2017
• 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