MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035473080

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

Patient Problems Headache (1880); Epilepsy (4407)

Event Date 02/06/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : the device remains implanted in the patient.

Event Description

It was reported that 18 days post procedure, following implantation with subject coils, the patient experienced severe progressive headaches and seizure requiring medications.Two days post discharge, the patient was readmitted for increased headaches.A multifocal right hemispheric meningoencephalic condition whose location and appearance compatible with a nice syndrome was observed in brain magnetic resonance imaging (mri).The manufacturer has requested patient status; however, as of today, no additional information is available.

Manufacturer Narrative

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 coil was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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.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 codes 'patient headache serious', 'patient complications' and 'patient neurological deficit'.

Event Description

It was reported that 18 days post procedure, following implantation with subject coils, the patient experienced severe progressive headaches and seizure requiring medications.Two days post discharge, the patient was readmitted for increased headaches.A multifocal right hemispheric meningoencephalic condition whose location and appearance compatible with a nice syndrome was observed in brain magnetic resonance imaging (mri).The manufacturer has requested patient status; however, as of today, no additional information is available.Additional information received on 08 mar 2024: treatments were administered during 1st hospitalization and prescribed on discharge.The medication prescribed was nefopam, morphine ketoprofen.The coil (subject device) performed as intended in the anterior communicating artery embolization procedure.The headache has now been resolved.The patient is currently on corticosteroid therapy and allergological tests are scheduled."nice syndrome" is clarified to be non ischemic cerebral enhancing".No further information is available.Update: it was reported that on (b)(6) 2024, the patient was managed for aneurysm rupture and embolized anterior communicating artery (5 coils implanted).On (b)(6) 2024, the patient experienced severe progressive headaches treated with nefopam, morphine, and ketoprofen, along with a generalized tonic-clonic seizure treated with levetiracetam.Two days post-discharge, on (b)(6) 2024, the patient was readmitted due to increased headaches.Brain magnetic resonance imaging (mri) revealed a multifocal right hemispheric meningoencephalic condition, resembling nice syndrome, treated with high-dose corticoids, and an allergist's opinion was requested.The occurrence of nice lesions has been described in the literature after endovascular treatment of intracranial aneurysms.Coils are the probable cause of this syndrome.The adverse event is related to the subject coils.Follow-up with internal medicine and imaging controls planned, alongside allergological tests.Because of the urgency in treating ruptured aneurysms, patch testing cannot be conducted, requiring the patient's admission through the emergency department, management in the usc (continuous monitoring unit), and engagement of internal medicine and allergology.Headache persists, with no additional information available.

• Brand Name: TARGET 360 SOFT 3MM X 8CM
• 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: 18825787
• MDR Text Key: 336771564
• Report Number: 3008881809-2024-00084
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540676436
• UDI-Public: 04546540676436
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0035473080
• Device Lot Number: 24543796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male