MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 6.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412060
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during vertebral aneurysm procedure the operator used the subject coil to deploy into the aneurysm.After the operator heard three beeps from the detacher, he retracted the microcatheter and the pusher wire, however, the subject coil came out into the parent artery.The operator tried to repass the subject coil across with the flow diverter to secure the loose coil but unsuccessfully.The subject coil had moved with the blood flow into the posterior inferior cerebellar artery (pica).The operator attempted several times to catch the subject coil with the stent retriever but unsuccessfully.The procedure was aborted.A surgical delay of 30-45 minutes was reported due to this event.Patient was placed on additional medication.Patient is undergoing diagnostic angiogram post op and then treatment of the initial aneurism that is still untreated, will have to be considered.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed due to the device was not returned.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.The power supply signaled that the coil was successfully detached and per the communication log the physician verified this under fluoro but after removal of the microcatheter and coil delivery wire, the coil came out into the parent vessel and then travelled to the during an attempt to deploy a flow diverter.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during vertebral aneurysm procedure the operator used the subject coil to deploy into the aneurysm.After the operator heard three beeps from the detacher, he retracted the microcatheter and the pusher wire, however, the subject coil came out into the parent artery.The operator tried to repass the subject coil across with the flow diverter to secure the loose coil but unsuccessfully.The subject coil had moved with the blood flow into the posterior inferior cerebellar artery (pica).The operator attempted several times to catch the subject coil with the stent retriever but unsuccessfully.The procedure was aborted.A surgical delay of 30-45 minutes was reported due to this event.Patient was placed on additional medication.Patient is undergoing diagnostic angiogram post op and then treatment of the initial aneurism that is still untreated, will have to be considered.

• Brand Name: TARGET TETRA 2.0MM X 6.0CM
• 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: 19421327
• Report Number: 3008881809-2024-00238
• Device Sequence Number: 7906140
• Product Code: HCG
• UDI-Device Identifier: 07613327578607
• UDI-Public: 07613327578607
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K222533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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 Catalogue Number: TG5412060
• Device Lot Number: 24698972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 06/16/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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: FLOW DIVERTER STENT (UNKNOWN); STENT RETRIEVER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female