MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036124080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure, the subject coil was stretched and the medical intervention was performed to recover the stretched coil and the anti-fibrinolytics was administered to the patient.No other information was provided.
Additional Manufacturer Narrative
Section a- age/gender: added.Section b2 outcomes attributed to ae- updated.Section b5 executive summary: updated.Section d1 product long description - corrected.Section d4 catalog # and lot/serial no./lot # : corrected.Section d gtin -corrected.F10 / h6 clinical signs code grid: updated.
Event or Problem Description
It was reported that during procedure, the subject coil was stretched and the medical intervention was performed to recover the stretched coil and the anti-fibrinolytics was administered to the patient.No other information was provided.Update information: additional information received on 4-jan-2023 indicated this incident also necessitated the use of expensive equipment not foreseen in order to attempt to recover the stretched coil (distal portion).Additionally, attempted extraction with two unsuccessful retriever stents.Abandonment of the coil in place when a clot developed at the aneurysm neck requiring intravenous injection of agrastat 25 ml with relay over 12 hours with heparin, without further complication.The coil is left in place with the distal portion within the right internal carotid artery.Based on the physician's opinion to the cause of this incident as it was a failure to release the coil.The patient has been discharged home without complications.
Event or Problem Description
It was reported that during procedure, the subject coil was stretched and the medical intervention was performed to recover the stretched coil and the anti-fibrinolytics was administered to the patient.No other information was provided.Additional information received on 4-jan-2023 indicated this incident also necessitated the use of expensive equipment not foreseen in order to attempt to recover the stretched coil (distal portion).Additionally, attempted extraction with two unsuccessful retriever stents.Abandonment of the coil in place when a clot developed at the aneurysm neck requiring intravenous injection of agrastat 25 ml with relay over 12 hours with heparin, without further complication.The coil is left in place with the distal portion within the right internal carotid artery.Based on the physician's opinion to the cause of this incident as it was a failure to release the coil.The patient has been discharged home without complications.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 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.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, a cause of undeterminable was assigned.

• Brand Name: TARGET 360 SOFT 7MM 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: 16092043
• Report Number: 3008881809-2023-00001
• Device Sequence Number: 6610329
• Product Code: HCG
• UDI-Device Identifier: 04546540676580
• UDI-Public: 04546540676580
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 01/12/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2024
• Device Model Number: M0036124080
• Device Catalogue Number: M0035477300
• Device Lot Number: 23352810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 01/04/2023; 01/11/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/06/2023; 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female