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

Model Number	M0036128300
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9561957
• Report Number: 3008881809-2020-00002
• Device Sequence Number: 11497240
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention