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

Catalog Number M0036127200

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Thrombosis (2100); Dysphasia (2195)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

The subject device remains implanted in the patient.

Event 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 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.

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 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.

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
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8813769
• MDR Text Key: 151840108
• Report Number: 3008881809-2019-00213
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: 07613327004632
• 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,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0036127200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEUROFORM STENT SYSTEM (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR