MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 3 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035442030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

This is the second of 2 reports.The patient event reported under this filling occured more than 3 month post-procedure and is related to another reported event that occurred 1 month post procedure filed under mfr report # 3008881809-2017-00440.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.However, tia (transient ischemic attack) is a known risk associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.Subject devices remain implanted.

Event Description

The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the left superior cerebellar artery.Post procedure the patient was neurologically assessed having a nihss of 0 and a mrs of 1.More than 3 month post-procedure, that patient experience a transient ischemic attack (tia) that was resolved the next day without residual effect.Medication hospitalization/prolonged hospitalization was undertaken.According to the physician, the tia were possibly related to the procedure and the stent.However it is unknown if the tia was related to the 2 implanted coils (subject devices).The patient was neurologically assessed at 2 month post procedure having a nihss of 0 and a mrs of 1.

• Brand Name: TARGET 360 NANO 2 MM X 3 CM
• 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: 7201593
• MDR Text Key: 97593886
• Report Number: 3008881809-2018-00045
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: M0035442030
• Device Lot Number: 19621521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2017
• 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
• Treatment: NEUROFORM ATLAS STENT (STRYKER); TARGET COIL (STRYKER)
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 62 YR