MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 4.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure once all implants had been detached and during the control runs which are done at the end of the procedure, clot formation was noted on the subject coil.The patient had to be given aggrastat infusion on the table which delayed the procedure.No further information is available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.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 device is not available; therefore, visual testing as well as functional testing cannot be performed.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.It was reported that during the procedure after implantation of the subject coil, clot formation was noticed on the subject coil once all implants had been detached and during the control runs which are done at the end of the procedure.The patient had to be given aggrastat infusion on the table which delayed the procedure.Based upon medical review, the event observed in this complaint is anticipated in nature as per the device risk assessment.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 this complaint.
Event or Problem Description
It was reported that during procedure once all implants had been detached and during the control runs which are done at the end of the procedure, clot formation was noted on the subject coil.The patient had to be given aggrastat infusion on the table which delayed the procedure.No further information is available.

• Brand Name: TARGET TETRA 2.0MM X 4.5CM
• 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: 20517247
• Report Number: 3008881809-2024-00493
• Device Sequence Number: 20803516
• Product Code: HCG
• UDI-Device Identifier: 07613327578591
• UDI-Public: (01)07613327578591(17)270128(10)24723169
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 11/04/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TG5412045
• Device Lot Number: 24723169
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown