MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035421030

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

This is 1 of 8 (coils) reports filed associated with this event.Subject devices remain implanted.

Event Description

The patient underwent successful stent assisted coil embolization of an aneurysm located in the basilar apex artery.It was reported that approximately 24 hours post procedure the patient experienced a transient ischemic attack (tia).Post procedure national institute of health stroke scale (nihhs) was 4 and modified ranking scale (mrs) was 4.The hospitalization was prolonged due to the tia and it resolved without residual effect.The physician believe that the tia was probably related to the stent device, the procedure, and possibly related to the implanted coils.The patient was assessed having a mrs of 1 at 2 months and a mrs of 0 at 6 months post the index procedure.

Manufacturer Narrative

Expiration date: updated.Manufacturing date: updated.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.

Event Description

The patient underwent successful stent assisted coil embolization of an aneurysm located in the basilar apex artery.It was reported that approximately 24 hours post procedure the patient experienced a transient ischemic attack (tia).Post procedure national institute of health stroke scale (nihhs) was 4 and modified ranking scale (mrs) was 4.The hospitalization was prolonged due to the tia and it resolved without residual effect.The physician believe that the tia was probably related to the stent device, the procedure, and possibly related to the implanted coils.The patient was assessed having a mrs of 1 at 2 months and a mrs of 0 at 6 months post the index procedure.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• 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: 6814903
• MDR Text Key: 83459534
• Report Number: 3008881809-2017-00262
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: M0035421030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 58 YR