MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036181040

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported that during embolization procedure the coil stuck in the aneurysm.It had been repositioned several times and then removed from the patient body together with the microcatheter.The device was found to be separated at the detachment zone.The coil was replaced, and procedure successfully completed without any patient consequences due to the event.

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.Information provided mentioned that there was intermittent flushing.In the case of this complaint it is most likely that the main coil encountered resistance and stuck while advancing through introducer sheath and microcatheter due to lack of continuous flush maintained during the procedure which is against the dfu for this product.The dfu states: 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.Also it has been reported that the coil was repositioned several times during the procedure which can also contribute to failure, all these factors together leading to the reported premature detachment inside patient, the friction within the introducer sheath and within the catheter.Based on the review of additional information there was no damage noted to the device prior to use.However, the investigation confirmed that there was an act or omission of an act that could have resulted in a different medical device response than intended by the manufacturer and/or expected by the user.

Event Description

It was reported that during embolization of an aneurysm located on the intercostal artery, after being repositioned several times, the coil became stuck in the aneurysm.It was decided to remove the coil from the patient¿s body together with the microcatheter, but the coil separated at the detachment zone.All of the coil was retrieved and procedure successfully completed without any patient consequences due to the event.

• Brand Name: TARGET XXL 360 10MM X 40CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6627046
• MDR Text Key: 77287172
• Report Number: 3008881809-2017-00179
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K161429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: M0036181040
• Device Lot Number: 19616561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 1 YR