MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 9CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036123090

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Neck Pain (2433)

Event Date 12/26/2016

Event Type  Injury  

Manufacturer Narrative

This is the 3rd of 5 (coils) reports filed associated with this event.Subject device remains implanted.

Event Description

The patient underwent successful stent assisted coil embolization of an aneurysm located in the basilar artery apex.Post procedure the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that 21 days post-procedure, the patient experienced right hand numbness.An arterial study treatment was performed of the right upper extremity via a venous doppler ultrasound which revealed a superficial venous thrombosis in the right cephalic vein above the elbow.No deep venous thrombosis was identified.The reported right hand numbness was ongoing.According to the physician, the event was probably related to the procedure, but unrelated to the stent.However it was unknown if the event was related to the implanted coils (subject devices).The patient was assessed having a modified ranking scale (mrs) of 1 at 2 months post the index procedure.No further information is available.

Manufacturer Narrative

Expiration date: added.Manufacturing date: added 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, neurological sequelae (right hand numbness) and thrombosis are known risks 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 artery apex.Post procedure the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that 21 days post-procedure, the patient experienced right hand numbness.An arterial study treatment was performed of the right upper extremity via a venous doppler ultrasound which revealed a superficial venous thrombosis in the right cephalic vein above the elbow.No deep venous thrombosis was identified.The reported right hand numbness was ongoing.According to the physician, the event was probably related to the procedure, but unrelated to the stent.However it was unknown if the event was related to the implanted coils (subject devices).The patient was assessed having a modified ranking scale (mrs) of 1 at 2 months post the index procedure.No further information is available.

Manufacturer Narrative

Executive summary: added: adverse event of right sided-neck pain was added.Sequence of events was edited for clarity.Patient code: added.Additional mfg narrative: added:adverse event of right sided-neck pain was added.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, right hand numbness, right sided neck pain (neurological sequelae), and thrombosis are known risks 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 artery apex.Post procedure the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that 20 days post-procedure, the patient experienced right sided neck pain that was resolved the next day without any no residual effects.It was also reported that 21 days post-procedure, the patient experienced right hand numbness that was ongoing.An arterial study treatment of the right upper extremity via a venous doppler ultrasound was performed for the right hand numbness.The arterial study revealed a superficial venous thrombosis in the right cephalic vein above the elbow.No deep venous thrombosis was identified.According to the physician, the right sided neck pain was possibly related to the procedure, but unrelated to the stent.However it was unknown if the right sided-neck pain was related to the implanted coils (subject devices).According to the physician, the right hand numbness was probably related to the procedure, but unrelated to the stent.However it was unknown if it was related to the implanted coils (subject devices).The patient was assessed having a modified ranking scale (mrs) of 1 at 2 months post the index procedure.No further information is available.

• Brand Name: TARGET XL 360 SOFT 3MM X 9CM
• 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: 6865455
• MDR Text Key: 86150161
• Report Number: 3008881809-2017-00321
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: M0036123090
• Device Lot Number: 19328750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2016
• 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
• Treatment: 4 TARGET COILS (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR