MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	26924
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent deployment occurred.Access was gained via the left femoral, with a 6 french sheath, for an in stent restenosis treatment procedure from the superficial femoral artery (sfa) to the proximal popliteal.The physician attempted to advance 2 separate innova stents over a non bsc guidewire but the stents started to deploy before entering the hub of the sheath from the force required to advance the stent delivery system over the non bsc guidewire.Neither stent entered the sheath or the body of the patient.The physician was able to implant a non bsc stent and post-dilated with a poba balloon.The case was completed with a good outcome and the patient is doing well.
Event or Problem Description
It was reported that inadvertent deployment occurred.Access was gained via the left femoral, with a 6 french sheath, for an in stent restenosis treatment procedure from the superficial femoral artery (sfa) to the proximal popliteal.The physician attempted to advance 2 separate innova stents over a non bsc guidewire but the stents started to deploy before entering the hub of the sheath from the force required to advance the stent delivery system over the non bsc guideire.Neither stent entered the sheath or the body of the patient.The physician was able to implant a non bsc stent and post-dilated with a poba balloon.The case was completed with a good outcome and the patient is doing well.Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds).The outer sheath, mid-shaft, and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.It was noticed that the stent was not in the device it was returned in the bag.The yellow thumbwheel lock was intact on the device.The pull handle was at the start position.The cis investigator rotated the thumbwheel to verify functionality of the device.The mid-shaft started to move proximally as designed with no issues.Research on the use of the guidewire that was used in this case showed that the guidewire was consistent with an.018.The.035 guidewire the physician requested was on back order therefore a unrecommended wire was used.This may have contributed to the inadvertent deployment which the customer experienced.A.035 amplatz test guidewire was inserted into the device with a slight hesitation due to the kink at the nosecone, the guidewire traveled through the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7938584
• Report Number: 2134265-2018-61606
• Device Sequence Number: 1998686
• Product Code: NIP
• UDI-Device Identifier: 08714729874089
• UDI-Public: 08714729874089
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/23/2018

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: 07/08/2021
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0022347101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO GLIDEWIRE; TERUMO GLIDEWIRE
• Patient Age: 64 YR