MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036128300

Device Problem Expulsion (2933)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

The subject device is unavailable to manufacturer.

Event Description

It was reported that during procedure, the subject coil was stretched during detachment and the detached coil protruded out of the aneurysm.The stent was placed to tack the proximal end of the coil down and completed the procedure.The following day (after procedure) patient found to have sudden onset of left sided weakness and right gaze preference.Stroke alert called and confirmed acute right frontal infarct.Heparin drip started and then discontinued about an hour later.Patient was monitored and improvement recognized with mild left sided weakness.The patient was discharged to rehab on (b)(6) 2019.No other information was provided.

Event Description

It was reported that during procedure, the subject coil was stretched during detachment and the detached coil protruded out of the aneurysm.The stent was placed to tack the proximal end of the coil down and completed the procedure.The following day (after procedure) patient found to have sudden onset of left sided weakness and right gaze preference.Stroke alert called and confirmed acute right frontal infarct.Heparin drip started and then discontinued about an hour later.Patient was monitored and improvement recognized with mild left sided weakness.The patient was discharged to rehab on (b)(6) 2019.No other information was provided.

Manufacturer Narrative

D4 expiration date: added.H4 manufacturing date: added.The edhr (electronic device history record) for the device lot is created and maintained in mes (manufacturing execution system).Automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that no anomalies noted to the device prior to use and the product was prepared as per dfu.Also, continuous flush was maintained.Stent was also placed to tack the proximal end of the coil down.While there are a number of potential causes for the reported "main coil stretched, main coil protrusion", because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.The reported "patient neurological deficit" and "patient stoke" are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

• Brand Name: TARGET XL 360 SOFT 8MM X 30CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9561957
• MDR Text Key: 176099259
• Report Number: 3008881809-2020-00002
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: M0036128300
• Device Catalogue Number: M0036128300
• Device Lot Number: 20332535
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SL-10 MICROCATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention