MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036123060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was implanted.
Event or Problem Description
It was reported that 6 months post stent-assisted coil embolization of the right middle cerebral artery bifurcation aneurysm, moderate coil compaction occurred.Re-intervention for residual filling of the target aneurysm was necessary.The procedure was resolved without residual effects.The physician opinion is that the adverse event is related to the procedure and to the coils (one target coil and several non-stryker coils).
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 could not be performed.No anomalies were noted to the target coil during the initial procedure and a number of non-stryker devices were also used during the initial procedure.A device related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, device labeling and/or risk documentation files.Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that 6 months post stent-assisted coil embolization of the right middle cerebral artery bifurcation aneurysm, moderate coil compaction occurred.Re-intervention for residual filling of the target aneurysm was necessary.The procedure was resolved without residual effects.The physician opinion is that the adverse event is related to the procedure and to the coils (one target coil and several non-stryker coils).

• Brand Name: TARGET XL 360 SOFT 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5809160
• Report Number: 3008881809-2016-00084
• Device Sequence Number: 639257
• Product Code: HCG
• UDI-Device Identifier: 07613327128277
• UDI-Public: (01)07613327128277(17)181031(10)18633157
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K123377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2016

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: 10/31/2018
• Device Catalogue Number: M0036123060
• Device Lot Number: 18633157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2016
• Supplement Report FDA Received Date: 12/19/2016
• 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
• Patient Age: 65 YR