MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036128300

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

Patient Problems Ruptured Aneurysm (4436); Thrombosis/Thrombus (4440)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the subject device was implanted.

Event Description

It was reported that the patient came for follow up and the aneurysm rupture (became unraveled), thrombosed were observed on imaging cta (computerized tomography angiography) head and neck.No other information was provided.

Manufacturer Narrative

Due to the automated mes system (manufacturing execution 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 and the device was not returned, an assignable cause of anticipated procedural complication was assigned.

Event Description

It was reported that the patient came for follow up and the aneurysm rupture (became unraveled), thrombosed were observed on imaging cta (computerized tomography angiography) head and neck.No other information was provided.

• Brand Name: TARGET XL 360 SOFT 8MM 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: 16912135
• MDR Text Key: 315011007
• Report Number: 3008881809-2023-00243
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: M0036128300
• Device Catalogue Number: M0036128300
• Device Lot Number: 20203418
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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
• Treatment: TARGET COILS (STRYKER).
• Patient Outcome(s): Other