MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036129300
Medical Device Problem Codes	Fracture (1260); Premature Activation (1484)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during middle cerebral artery ruptured aneurysm coiling procedure, the physician noticed that the subject coil loop was obstructing flow into the vessel prior to the deployment.Physician decided to pull the subject coil out and resheath it.While withdrawing, the subject coil stretched, broke and detached prematurely within the microcatheter.The physician pulled the microcatheter and intermediate catheter out.Half of the subject coil was in the aneurysm the other half was outside the aneurysm from middle cerebral artery to cervical internal carotid artery.Physician attempted to retrieve the broken coil using a stent retriever and a micro snare kit, however, failed to do so.Physician decided to leave the broken subject coil inside patient as it was not flow obstructing at the end of the procedure.During the retrieval process some pieces of the broken coil were pulled out of the catheters.Additional medication was given to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿ updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿ updated.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/microscopic inspection, the coil delivery wire and introducer sheath were not returned.The main coil was seen to be broken, stretched and the suture damaged.During functional inspection, main coil prematurely detached/separated during use was not confirmed.Un-retrieved device fragments was not applicable.Main coil stretched was confirmed during visual inspection.Main coil broken/fractured during use was confirmed during visual inspection.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 main coil prematurely detached/separated during use was not confirmed during analysis.As the coil delivery wire or detachment zone was not returned.The reported un-retrieved device fragments could not be duplicated; however, the analysis results are consistent with the reported event.The reported main coil stretched was confirmed during analysis.The reported main coil broken/fractured during use was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer is, during the retrieval process pieces of the stretched coil was pulled out of the catheters.The coil unravelled and pieces of that were retrieved.A 6mm stent retriever was used as medical intervention.The patient¿s anatomy was normal.During analysis, the coil delivery wire and introducer sheath were not returned.The main coil was seen to be broken, stretched and the suture damaged.Functional testing could not be carried out.An assignable cause of ¿not confirmed¿ will be assigned to the as reported ¿main coil prematurely detached/separated during use¿ as the event was not confirmed during the analysis.An assignable cause of ¿procedural factors¿ will be assigned to the as reported ¿un-retrieved device fragments¿, ¿main coil stretched¿ and ¿main coil broken/fractured during use¿ 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 ¿procedural factors¿ will be assigned to the as analyzed ¿main coil stretched¿, ¿main coil suture damaged¿ and ¿main coil broken/fractured during use¿ these defects 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.
Event or Problem Description
It was reported that during middle cerebral artery ruptured aneurysm coiling procedure, the physician noticed that the subject coil loop was obstructing flow into the vessel prior to the deployment.Physician decided to pull the subject coil out and resheath it.While withdrawing, the subject coil stretched, broke and detached prematurely within the microcatheter.The physician pulled the microcatheter and intermediate catheter out.Half of the subject coil was in the aneurysm the other half was outside the aneurysm from middle cerebral artery to cervical internal carotid artery.Physician attempted to retrieve the broken coil using a stent retriever and a micro snare kit, however, failed to do so.Physician decided to leave the broken subject coil inside patient as it was not flow obstructing at the end of the procedure.During the retrieval process some pieces of the broken coil were pulled out of the catheters.Additional medication was given to the patient.

• Brand Name: TARGET XL 360 SOFT 9MM X 30CM
• 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: 18633977
• Report Number: 3008881809-2024-00040
• Device Sequence Number: 15442468
• Product Code: HCG
• UDI-Device Identifier: 04546540711618
• UDI-Public: 04546540711618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• 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): 04/05/2024

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 Expiration Date: 08/12/2026
• Device Catalogue Number: M0036129300
• Device Lot Number: 24484456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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); INTERMEDIATE CATHETER (UNKNOWN); MICRO SNARE KIT (UNKNOWN); TREVO STENT RETRIEVER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown