MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4 MM X 15 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035434150
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Codes	Thrombus (2101); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during stent-assisted coil embolization of a ruptured aneurysm located in the left posterior communicating artery (pcomm), midway through deployment of the second coil (subject device), the delivery wire prematurely detached from the coil and the coil migrated.Angiograms showed thrombus propagation in the left pcomm and blood flow stasis in the distal branches of the left pcomm.Antiplatelet drug (tirofiban) was administered.A stent was partially deployed in the terminal ica to complete the coiling and then the stent was fully deployed to jail the migrated coil.The distal part of the coil however still migrated outside the deployed stent into the to the internal carotid artery (ica) bifurcation.Movement of the coil with blood pulsation was noted.Another stent was deployed to secure and jail the still distally migrated coil.Thrombus in the left pcomm was resolved and blood flow was restored.
Additional Manufacturer Narrative
A review of the device history record could not be performed because the lot number was not reported.The subject device is not available.In the case of this complaint it is most probable that procedural or anatomical factors encountered during the clinical procedure contributed to the reported premature detachment, possibly leading the main coil migration, and patient thrombosis (treated vessel).This however cannot be conclusively determined.Therefore, an assignable cause of 'undeterminable' will be assigned to these reported issues as the device was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.Vessel thrombosis is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this patient thrombosis.(b)(4).
Event or Problem Description
It was reported that during stent-assisted coil embolization of a ruptured aneurysm located in the left posterior communicating artery (pcomm), midway through deployment of the second coil (subject device), the delivery wire prematurely detached from the coil and the coil migrated.Angiograms showed thrombus propagation in the left pcomm and blood flow stasis in the distal branches of the left pcomm.Antiplatelet drug (tirofiban) was administered.A stent was partially deployed in the terminal ica to complete the coiling and then the stent was fully deployed to jail the migrated coil.The distal part of the coil however still migrated outside the deployed stent into the to the internal carotid artery (ica) bifurcation.Movement of the coil with blood pulsation was noted.Another stent was deployed to secure and jail the still distally migrated coil.Thrombus in the left pcomm was resolved and blood flow was restored.

• Brand Name: TARGET HELICAL ULTRA 4 MM X 15 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7715266
• Report Number: 3008881809-2018-00317
• Device Sequence Number: 11112212
• Product Code: HCG
• UDI-Device Identifier: 04546540676122
• UDI-Public: 04546540676122
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0035434150
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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: MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR