MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 9CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036123090
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization, when the coil was repositioned several times in the aneurysm, the coil was stretched and broke off.The distal side of the coil was deployed in the aneurysm and the stretched part of the coil was protruded from the aneurysm.The microcatheter was flushed to push the protruding part of the coil into the aneurysm.The proximal side of the coil was able to be retrieved from the patient's body.The procedure was completed without clinical impact to the patient.
Additional Manufacturer Narrative
The device history record 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.Based on information from the complaint intermittent flush was used during the procedure.As per the dfu "warning: in order to achieve optimal performance of the target detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between the femoral sheath and guiding catheter, the 2-tip microcatheter and guiding catheters, and the 2-tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the target detachable coil.It is likely that the use of intermittent flush caused friction issues leading to the coil to stretch and break during re-positioning and that this resulted in the coil protrusion and the cause for the reported complaint is believed to be related to use error.Expiration date: added, manufacturing date: added.
Event or Problem Description
It was reported that during coil embolization, when the coil was repositioned several times in the aneurysm, the coil was stretched and broke off.The distal side of the coil was deployed in the aneurysm and the stretched part of the coil was protruded from the aneurysm.The microcatheter was flushed to push the protruding part of the coil into the aneurysm.The proximal side of the coil was able to be retrieved from the patient's body.The procedure was completed without clinical impact to the patient.

• Brand Name: TARGET XL 360 SOFT 3MM X 9CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5709141
• Report Number: 3008881809-2016-00025
• Device Sequence Number: 490584
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: (01)07613327128284(17)181231(10)18764085
• Combination Product (Y/N): N
• PMA/510(K) Number: K123377
• 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): 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: M0036123090
• Device Lot Number: 18764085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2016
• Supplement Report FDA Received Date: 01/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR