MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN TRANSEND .014 FLOPPY 300 CM ( IC 300 ); WIRE, GUIDE, CATHETER

Catalog Number	M003468150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that during the treatment of the 90% of stenosed left internal carotid (ic) (c3- c4), the stent was deployed successfully.Post procedure while attempting to remove the guidewire from the patient, the tip of the subject guidewire (about 3 cm from the tip) and the distal edge of the stent got stuck.Following several attempts to remove the guidewire using different microcatheters, the balloon catheter was inflated inside the stent and the guidewire was attempted to be removed with force, but the guidewire was unable to be removed and the stent migrated to the ic-petrous portion.Then the stent and the guidewire were tried to be retracted to the guide catheter, but the stent was stuck near the ic bifurcation.An attempt to retrieve the stent using a gooseneck snare failed as well.The guidewire remained in the patient as well as the stent, which was dislodged to the ic bifurcation.There was no neurological deficit observed at the moment due to sufficient collateral circulation.No further information is provided.
Additional Manufacturer Narrative
Additional information received on jan 11th 2017 and it is confirmed that the subject guidewire was completely removed from the patient.(b)(4).However due to the reported medical intervention,this event is still reportable as a serious injury.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The reported issues are covered in the device directions for use (dfu).The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Based on the information available the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that during the treatment of the 90% of stenosed left internal carotid (ic) (c3- c4), the stent was deployed successfully.Post procedure while attempting to remove the guidewire from the patient, the tip of the subject guidewire (about 3 cm from the tip) and the distal edge of the stent got stuck.Following several attempts to remove the guidewire using different microcatheters, the balloon catheter was inflated inside the stent and the guidewire was attempted to be removed with force, but the guidewire was unable to be removed and the stent migrated to the ic-petrous portion.Then the stent and the guidewire were tried to be retracted to the guide catheter, but the stent was stuck near the ic bifurcation.An attempt to retrieve the stent using a gooseneck snare failed as well.The stent remained in the patient however, the guidewire was completely removed from the patient.There was no adverse clinical consequences to the patient a result of the procedure.

• Brand Name: TRANSEND .014 FLOPPY 300 CM ( IC 300 )
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 6221642
• Report Number: 3004859241-2017-00001
• Device Sequence Number: 938377
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: (01)08714729441748(17)180314(10)19035681
• Combination Product (Y/N): N
• PMA/510(K) Number: K022357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2019
• Device Catalogue Number: M003468150
• Device Lot Number: 19035681
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 02/07/2017
• 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: WINGSPAN STENT (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR