MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036123060

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

Patient Problems Neuropathy (1983); Cerebral Edema (4403)

Event Date 05/23/2023

Event Type  Injury  

Manufacturer Narrative

This is the 1 of 3 mdrs h3 other text : the device remains implanted inside the patient's vasculature.

Event Description

It was reported that during an endovascular procedure for a ruptured aneurysm, physician used the subject coil and flow diverting stent to treat the patient.Post procedure on (b)(6)2023, patient was readmitted due to fine motor disturbance of right hand since (b)(6), facialis weakness on right hand.Multifocal subcortical edema was notice in the ct (computed tomography) and mri (magnetic resonance imaging).According the the physician it is caused by contact allergy (new) type iv to nickel + cobalt.No additional information available.

Event Description

It was reported that during an endovascular procedure for a ruptured aneurysm, physician used the subject coil and flow diverting stent to treat the patient.Post procedure on (b)(6) 2023, patient was readmitted due to fine motor disturbance of right hand since 16th may, facialis weakness on right hand.Multifocal subcortical edema was notice in the ct (computed tomography) and mri (magnetic resonance imaging).According the the physician it is caused by contact allergy (new) type iv to nickel + cobalt.No additional information available.

Manufacturer Narrative

This is the 1 of 3 mdrs.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint of patient complications and patient neurological deficit.

• Brand Name: TARGET XL 360 SOFT 3MM X 6CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17326929
• MDR Text Key: 319092365
• Report Number: 3008881809-2023-00350
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327128277
• UDI-Public: 07613327128277
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0036123060
• Device Catalogue Number: M0036123060
• Device Lot Number: 23888326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: PIPELINE VANTAGE FLOW DIVERTING STENT (MEDTRONIC).
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female