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

Model Number	H74939293071830
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: over the age of 18 years old.(b)(4).
Event or Problem Description
It was reported that partial stent deployment occurred.A 7x180x130 innova¿ stent was selected in a percutaneous transluminal angioplasty procedure to treat the moderately tortuous chronically total occluded (thrombotic) lesion located in the right superficial femoral artery.A non bsc guidewire passed through the lesion and a parachute device was placed due to the thrombotic lesion.The lesion was pre-dilated with a coyote es2mm-40mm balloon catheter.The innova¿ stent was advanced via a contralateral approach and the deployment was initiated into the parachute and deployment stopped at 3.4cm of deployment.The pull grip was then pulled and tension was applied to the stent delivery system and the innova¿ stent gradually started to deploy.The stent delivery system and the parachute were removed together and were replaced with a non bsc guidewire.Another 7x180x130 innova¿ stent was then placed on the proximal side of the initial 7x180x130 innova¿ stent.No patient complications were reported and the patient¿s condition was good.
Additional Manufacturer Narrative
Device evaluated by manufacturer:returned product consisted of an innova self-expanding stent delivery system (sds) with a.014 guidewire stuck in the device.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 guidewire was protruding from the distal end approximately 6cm from the tip.The wire was protruding from the proximal end approximately 139.5cm from the handle.The handle was opened to inspect for further internal damage.It was noticed that the proximal inner was prolapsed.The clip in the handle was not completely latched.The stent was not returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).
Event or Problem Description
It was reported that partial stent deployment occurred.A 7x180x130 innova¿ stent was selected in a percutaneous transluminal angioplasty procedure to treat the moderately tortuous chronically total occluded (thrombotic) lesion located in the right superficial femoral artery.A non bsc guidewire passed through the lesion and a parachute device was placed due to the thrombotic lesion.The lesion was pre-dilated with a coyote es2mm-40mm balloon catheter.The innova¿ stent was advanced via a contralateral approach and the deployment was initiated into the parachute and deployment stopped at 3.4cm of deployment.The pull grip was then pulled and tension was applied to the stent delivery system and the innova¿ stent gradually started to deploy.The stent delivery system and the parachute were removed together and were replaced with a non bsc guidewire.Another 7x180x130 innova¿ stent was then placed on the proximal side of the initial 7x180x130 innova¿ stent.No patient complications were reported and the patient¿s condition was good.

• 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: 6830016
• Report Number: 2134265-2017-08591
• Device Sequence Number: 13844585
• Product Code: NIP
• UDI-Device Identifier: 08714729874140
• UDI-Public: (01)08714729874140(17)20190630(10)19408968
• 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): 08/09/2017

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: 06/30/2019
• Device Model Number: H74939293071830
• Device Catalogue Number: 39293-07183
• Device Lot Number: 19408968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1