MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5 MM X 10 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475100
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Aneurysm (1708); Intracranial Hemorrhage (1891); Rupture (2208)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available, the exact cause for the reported event of coil protrusion could not be determined.As the device was not returned, the exact cause for the difficulties encountered with the device cannot be definitively determined.However, patient aneurysm burst, patient hemorrhage are known risks associated with endovascular procedures and is noted as such in the device directions for use (dfu); therefore, an assignable cause of anticipated procedural complication was assigned to this event.The subject device remains implanted.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil (subject device) perforated and protruded out of the aneurysm causing the aneurysm to burst and bleeding to occur.The patient was treated with protamine and the aneurysm was coiled successfully and the bleeding stopped.The patient is recovering.There is no further information available.

• Brand Name: TARGET 360 SOFT 5 MM X 10 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7383134
• Report Number: 3008881809-2018-00139
• Device Sequence Number: 19267722
• Product Code: HCG
• UDI-Device Identifier: 04546540676498
• UDI-Public: (01)04546540676498(17)180731(10)18504043
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K102672
• 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
• Report Date (Section B): 03/29/2018

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: 07/31/2018
• Device Model Number: M0035475100
• Device Catalogue Number: M0035475100
• Device Lot Number: 18504043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/29/2018
• 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: Other; Required Intervention
• Patient Age: 61 YR