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

Model Number	H74939293054030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that inadvertent deployment occurred.A 5x40x130 innova stent was selected for use during a stent placement procedure in the patient's left popliteal artery.During the procedure, inside of the patient, the device started deploying as soon as the stent delivery system was inserted through the hub of the sheath.This occurred before the physician intentionally started the deployment process.The physician was able to retrieve the stent and the patient was not harmed.A 5x60 innova stent was then used to complete the procedure without issue.No patient complications were reported.The patient's status after the procedure was fine.
Additional Manufacturer Narrative
Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system.The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The device returned with the thumbwheel lock intact and the pull rack was at the start position.The outer sheath was kinked at the nosecone.No other damage on the shaft was noticed.The stent was returned inside of the sheath; however, it was partially deployed approximately 6.5cm from the distal end of the markerband.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks were attributable to handling of the device.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that inadvertent deployment occurred.A 5x40x130 innova¿ stent was selected for use during a stent placement procedure in the patient's left popliteal artery.During the procedure, inside of the patient, the device started deploying as soon as the stent delivery system was inserted through the hub of the sheath.This occurred before the physician intentionally started the deployment process.The physician was able to retrieve the stent and the patient was not harmed.A 5x60 innova¿ stent was then used to complete the procedure without issue.No patient complications were reported.The patient's status after the procedure was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system.The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The device returned with the thumbwheel lock intact and the pull rack was at the start position.The outer sheath was kinked at the nosecone.No other damage on the shaft was noticed.The stent was returned inside of the sheath; however, it was partially deployed approximately 6.5cm from the distal end of the markerband.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks were attributable to handling of the device.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that inadvertent deployment occurred.A 5x40x130 innova¿ stent was selected for use during a stent placement procedure in the patient's left popliteal artery.During the procedure, inside of the patient, the device started deploying as soon as the stent delivery system was inserted through the hub of the sheath.This occurred before the physician intentionally started the deployment process.The physician was able to retrieve the stent and the patient was not harmed.A 5x60 innova¿ stent was then used to complete the procedure without issue.No patient complications were reported.The patient's status after the procedure 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: 7664407
• Report Number: 2134265-2018-06007
• Device Sequence Number: 2355139
• Product Code: NIP
• UDI-Device Identifier: 08714729873907
• UDI-Public: 08714729873907
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: 09/30/2019
• Device Model Number: H74939293054030
• Device Catalogue Number: 39293-05403
• Device Lot Number: 19684654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR