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	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis (2100)
Date of Event	04/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that during stent assisted coiling of aneurysm, the subject main coil proximal section stretched during implantation, broke and protruded from the aneurysm into the parent vessel.Thrombosis on the stretched coil occurred.Platelet aggregation inhibitor medication was administered.The patient adverse consequence was a stroke of unknown severity.According to the physician, it is difficult to know if the coil got tangled in coil mass, wrapped around a strut of a the stent, or some other cause.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing; the anatomy was noted to have been of mild tortuosity.The damage noted to the device is likely to have contributed to the patient complications.Physician considered the likely cause of the coil damage was due to "coil got tangled in coil mass, wrapped around a strut of the neuroform stent, or some other cause".Because a definitive cause for the reported events could not be determined following review of available information and because the product was not returned, a cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during stent assisted coiling of aneurysm, the subject main coil proximal section stretched during implantation, broke and protruded from the aneurysm into the parent vessel.Thrombosis on the stretched coil occurred.Platelet aggregation inhibitor medication was administered.The patient adverse consequence was a stroke of unknown severity.According to the physician, it is difficult to know if the coil got tangled in coil mass, wrapped around a strut of a the stent, or some other cause.

• 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: 5729080
• Report Number: 3008881809-2016-00038
• Device Sequence Number: 16299110
• Product Code: HCG
• UDI-Device Identifier: 04546540676122
• UDI-Public: (01)04546540676122(17)181130(10)18684562
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K112385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2016

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: 11/30/2018
• Device Catalogue Number: M0035434150
• Device Lot Number: 18684562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2016
• Supplement Report FDA Received Date: 10/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability