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

Model Number	H74939293061830
Medical Device Problem Codes	Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent deployment difficulties and catheter entrapment occurred.Vascular access was obtained via a contralateral approach using a 6f introducer sheath.The chronically total occluded 30cm target lesion was located in the severely tortuous and severely calcified superficial femoral artery (sfa).Intravascular ultrasound (ivus) was used and a non-bsc guidewire was crossed to the lesion.Then the guidewire was exchanged to another non-bsc guidewire for stronger support.After predilation with a 4mm balloon catheter, a 6mm-180mm/130cm innova¿ stent was advanced to the distal sfa.While attempting to release the stent, the response of the thumbwheel was not good and the dial of the thumbwheel stopped without reaching in 12cm.The white arrow was observed.Then the pull grip was pulled to deploy the stent, but it stopped deploying about the remaining 3cm of the stent.Finally the stent was deployed by pulling the whole delivery system.Upon withdrawal, the stent delivery system got stuck on the guidewire.After several attempts, the device was pulled out with the guidewire together.Then the guidewire was crossed again to the lesion and a non-bsc stent was placed in the proximal lesion.The procedure was completed successfully.No patient complications were reported and the patient status was fine.
Additional Manufacturer Narrative
Updated: device avail.For eval; returned to mfr.On; device returned to mfr; device evaluated by mfr; eval summary attached; method codes; result codes; conclusion codes device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds) with a.014 guidewire inside of the device.The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The outer sheath had a slight buckling at the nosecone.The stent was not returned.The guidewire that was frozen in the device was protruding out of the distal end approximately 17 cm from the tip and protruding out of the proximal end approximately 123 cm.The device was viewed and the handle was opened to find additional damage.It was noticed that the proximal inner was prolapsed.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 deployment difficulties and catheter entrapment occurred.Vascular access was obtained via a contralateral approach using a 6f introducer sheath.The chronically total occluded 30 cm target lesion was located in the severely tortuous and severely calcified superficial femoral artery (sfa).Intravascular ultrasound (ivus) was used and a non-bsc guidewire was crossed to the lesion.Then the guidewire was exchanged to another non-bsc guidewire for stronger support.After predilation with a 4 mm balloon catheter, a 6 mm-180 mm/130 cm innova¿ stent was advanced to the distal sfa.While attempting to release the stent, the response of the thumbwheel was not good and the dial of the thumbwheel stopped without reaching in 12 cm.The white arrow was observed.Then the pull grip was pulled to deploy the stent, but it stopped deploying about the remaining 3 cm of the stent.Finally the stent was deployed by pulling the whole delivery system.Upon withdrawal, the stent delivery system got stuck on the guidewire.After several attempts, the device was pulled out with the guidewire together.Then the guidewire was crossed again to the lesion and a non-bsc stent was placed in the proximal lesion.The procedure was completed successfully.No patient complications were reported and the patient 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: 6370163
• Report Number: 2134265-2017-01430
• Device Sequence Number: 577810
• Product Code: NIP
• UDI-Device Identifier: 08714729874058
• UDI-Public: (01)08714729874058(17)20190731(10)0019527257
• 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): 02/07/2017

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: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 0019527257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1