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

Catalog Number M0036129300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

This is 1 of 2 reports.H3 other text : the subject device was implanted.

Event Description

It was reported that during an anterior communicating artery complex (acom) procedure as it was performed under general anesthesia via right radial access.The thrombus formation was observed and it was resolved with iv integrillin.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes (manufacturing execution system) 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.The event description indicates the adverse event was possibly related to the target coils.No device malfunction was reported.An assignable cause of anticipated procedural complication will be assigned to this complaint investigation.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 with the directions for use, product labeling and/or risk documentation files.

Event Description

It was reported that during an anterior communicating artery complex (acom) procedure as it was performed under general anesthesia via right radial access.The thrombus formation was observed and it was resolved with iv integrillin.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 9MM X 30CM
• Type of Device: 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: 18823124
• MDR Text Key: 336733013
• Report Number: 3008881809-2024-00082
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540711618
• UDI-Public: 04546540711618
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0036129300
• Device Lot Number: 24170576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 75 KG