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 Code	Thrombus (2101)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during coil embolization procedure for aneurysm located at the posterior communicating artery, the subject coil deployed prematurely.The angiograms several minute later indicated thrombus propagation in the left posterior communicating artery and flow stasis in the distal branches of the left communicating artery.Antiplatelet medication (tirofiban) was given.Stenting of the aneurysm was undertaken to assist the completion of the coil embolization and to jail the migrated coil against the vessel wall.However, the distal part of the subject coil was still migrated outside the deployed stent into the internal carotid artery (ica) bifurcation.The angiograms showed movement of the coil with blood pulsation; therefore, another stent was deployed to secure and jail the distally migrated coil.The thrombus in the left post communicating artery was resolved and blood flow was restored.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection of the returned coil, the deliver wire was noted to be kinked and the main coil was prematurely detached/separated.The detachment was noted to be due to a physical break at the detachment zone.The proximal contact of the coil was found intact.The main coil was implanted in the patient; therefore, was not returned.Functional testing could not be performed due to the condition of the returned device.The reported complaint was confirmed based on the visual inspection.The main coil appeared to have detached due to a physical break at the detachment zone.It is likely that the main coil was damaged during use resulting in the premature detachment and subsequent migration and thrombosis.An assignable cause of procedural factors was assigned to the as reported and as analyzed issues 'main coil prematurely detached/separated inside patient' and to the as reported 'main coil migration', 'patient thrombosis (treated vessel)'.An assignable cause of handling damage was assigned to the as analyzed 'coil delivery wire kinked/bent', as the issue was due to handling of the product or portion of the product during clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.Expiration date: added.Product available to stryker: updated.Device evaluated by mfg: updated.Summary attached: updated.Manufacturing date: added.
Event or Problem Description
It was reported that during coil embolization procedure for aneurysm located at the posterior communicating artery, the subject coil deployed prematurely.The angiograms several minute later indicated thrombus propagation in the left posterior communicating artery and flow stasis in the distal branches of the left communicating artery.Antiplatelet medication (tirofiban) was given.Stenting of the aneurysm was undertaken to assist the completion of the coil embolization and to jail the migrated coil against the vessel wall.However, the distal part of the subject coil was still migrated outside the deployed stent into the internal carotid artery (ica) bifurcation.The angiograms showed movement of the coil with blood pulsation; therefore, another stent was deployed to secure and jail the distally migrated coil.The thrombus in the left post communicating artery 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: 7690720
• Report Number: 3008881809-2018-00308
• Device Sequence Number: 10950481
• 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): 09/04/2018

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 Expiration Date: 03/27/2021
• Device Catalogue Number: M0035434150
• Device Lot Number: 20410652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 09/04/2018
• 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: 2 NEUROFORM ATLAS STENT (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR