MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036127200
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis (2100); Dysphasia (2195)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device remains implanted in the patient.
Event or Problem Description
It was reported during a stent assisted coiling of aneurysm at the middle cerebral artery(mca) branch, the coil(subject device) was repositioned and wrapped around the stent.The patient returned with an acute occlusion of the m2 branch due to in-stent thrombosis.The physician administered tpa (tissue plasminogen activator) and other medication to breakup the clot and restore blood flow, no other medical interventions were performed.It was reported the patient is stable however, patient was reported to have continued stoke symptoms and aphasia as a result of the event.No further information is available.
Event or Problem Description
It was reported during a stent assisted coiling of aneurysm at the middle cerebral artery(mca) branch, the coil(subject device) was repositioned and wrapped around the stent.The patient returned with an acute occlusion of the m2 branch due to in-stent thrombosis.The physician administered tpa (tissue plasminogen activator) and other medication to breakup the clot and restore blood flow, no other medical interventions were performed.It was reported the patient is stable however, patient was reported to have continued stoke symptoms and aphasia as a result of the event.No further information is available.
Additional Manufacturer Narrative
Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Additional information provided by the customer indicated that anatomy was very tortuous.Therefore, this complaint appears to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu (direction for use), but performance was limited due to procedural factors during use.
Event or Problem Description
It was reported during a stent assisted coiling of aneurysm at the middle cerebral artery(mca) branch, the coil(subject device) was repositioned and wrapped around the stent.The patient returned with an acute occlusion of the m2 branch due to in-stent thrombosis.The physician administered tpa (tissue plasminogen activator) and other medication to breakup the clot and restore blood flow, no other medical interventions were performed.It was reported the patient is stable however, patient was reported to have continued stoke symptoms and aphasia as a result of the event.No further information is available.
Additional Manufacturer Narrative
H6 device code grid: updated.H10 additional mfg narrative: updated to include coil protrusion.Investigation was updated to included coil protrusion.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Based on the updated investigation findings, a cause of procedural factors has been assigned to this investigation.

• Brand Name: TARGET XL 360 SOFT 7MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8813769
• Report Number: 3008881809-2019-00213
• Device Sequence Number: 2563498
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: 07613327004632
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2019

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 Catalogue Number: M0036127200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/23/2019; 08/19/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/13/2019; 09/09/2019
• 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: NEUROFORM STENT SYSTEM (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR