MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 2.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	TG5412025
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Embolism/Embolus (4438)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is implanted in the patient.
Event or Problem Description
It was reported that during an endovascular procedure for a ruptured pcom (posterior communicating artery) aneurysm when deployed the subject coil, it came out of the aneurysm and got lodge in the distal mca (middle cerebral artery) branch.The physician tried to retrieve the migrated subject coil using a stent retriever but was unsuccessful, instead there was hemorrhage while trying to retrieve the migrated coil.This resulted in embolization of unintended vessel in patient, thus vessel had to be sacrificed to stop the bleed while also leaving the migrated coil in the patient vasculature.Physician feels that the anatomy and/or location of intended area of treatment may have contributed to the reported event.There was a surgical delay of unknown duration due to the reported issue.No other information is available.
Event or Problem Description
It was reported that during an endovascular procedure for a ruptured pcom (posterior communicating artery) aneurysm when deployed the subject coil, it came out of the aneurysm and got lodge in the distal mca (middle cerebral artery) branch.The physician tried to retrieve the migrated subject coil using a stent retriever but was unsuccessful, instead there was hemorrhage while trying to retrieve the migrated coil.This resulted in embolization of unintended vessel in patient, thus vessel had to be sacrificed to stop the bleed while also leaving the migrated coil in the patient vasculature.Physician feels that the anatomy and/or location of intended area of treatment may have contributed to the reported event.There was a surgical delay of unknown duration due to the reported issue.No other 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.Based upon medical review, the harm 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.

• Brand Name: TARGET TETRA 2.0MM X 2.5CM
• 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: 17263683
• Report Number: 3008881809-2023-00331
• Device Sequence Number: 18157908
• Product Code: HCG
• UDI-Device Identifier: 07613327578577
• UDI-Public: 07613327578577
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K222533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2026
• Device Model Number: TG5412025
• Device Catalogue Number: TG5412025
• Device Lot Number: 24112909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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: TIGER 13 STENT RETRIEVER (UNKNOWN).; TIGER 17 STENT RETRIEVER (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown