MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474150
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a ruptured aneurysm coiling case, during deployment of the second coil (subject device), a loop of coil herniated out of the aneurysm and into the right internal carotid artery (ica).While pulling this loop of coil back into the microcatheter, the loop of coil broke off and partially deployed in the right ica.Multiple snares were used to try to remove the coil from the right ica, but this was unsuccessful.Right internal carotid artery cerebral angiogram showed no thrombus formation on the loop of coil and no stenosis or flow limitation.
Event or Problem Description
It was reported during a ruptured aneurysm coiling case, during deployment of the second coil (subject device), a loop of coil herniated out of the aneurysm and into the right internal carotid artery (ica).While pulling this loop of coil back into the microcatheter, the loop of coil broke off and partially deployed in the right ica.Multiple snares were used to try to remove the coil from the right ica, but this was unsuccessful.Right internal carotid artery cerebral angiogram showed no thrombus formation on the loop of coil and no stenosis or flow limitation.
Additional 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.During visual inspection, it was observed that the subject device was returned with the microcatheter.The subject coil delivery wire was seen to be kinked/bent, and the main coil was found to be stretched.The main coil suture was seen to be damaged.Functional inspection was not required as the returned coil was not fractured, and the entire coil was returned.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 event was confirmed during device analysis as the device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.However, the main coil was not fractured, and the entire coil was returned.It was reported that during placement of the second coil, a loop herniated out of the aneurysm and into the right internal carotid artery (ica).While pulling the loop back into the microcatheter, the physician reported that the coil broke and deployed in the ica.However, based on the returned device inspection it was confirmed that the coil had not broken but it was extensively stretched which may have been interpreted as a break by the physician.During analysis, it was confirmed that the entire coil was returned.An assignable cause of not confirmed will be assigned to the as reported codes 'main coil broken/fractured during use¿, 'un-retrieved device fragments'.An assignable cause of procedural factors will be assigned to the as reported 'main coil protrusion' and the as analyzed 'main coil suture damage' and 'main coil stretched' as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of handling damage will be assigned to the as analyzed coil delivery wire kinked/bent since these issues are likely to be associated with handling of the product or portion of the product during the clinical procedure.

• Brand Name: TARGET 360 SOFT 4MM X 15CM
• Common Device Name: 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: 20923073
• Report Number: 3008881809-2024-00596
• Device Sequence Number: 5294067
• Product Code: HCG
• UDI-Device Identifier: 04546540676481
• UDI-Public: (01)04546540676481(17)270611(10)24971160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0035474150
• Device Lot Number: 24971160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER).; SNARE (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown