MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036122060
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 2 reports.H3 other text : the subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure after deployment of the subject coil device, the subject coil was protruding into the neck of the aneurysm as there was concern for compromise flow to the mca (middle cerebral artery) vasculature.Therefore, the stent was implanted to support the subject protruding coil and the medication was administered to the patient.The last visit was for the 12-month follow up, conducted on (b)(6) 2023, and the patient had mrs (modified rankin scale) and nihss (national institute of health stroke scale) score of 0.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.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.Based on the information provided the device was confirmed to be in good condition prior to use and there is no indication of any use issue.In the physicians opinion the device performed as intended.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 undeterminable was assigned.
Event or Problem Description
It was reported that during procedure after deployment of the subject coil device, the subject coil was protruding into the neck of the aneurysm as there was concern for compromise flow to the mca (middle cerebral artery) vasculature.Therefore, the stent was implanted to support the subject protruding coil and the medication was administered to the patient.The last visit was for the 12-month follow up, conducted on (b)(6) 2023, and the patient had mrs (modified rankin scale) and nihss (national institute of health stroke scale) score of 0.

• Brand Name: TARGET XL 360 SOFT 2MM X 6CM
• 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: 18668820
• Report Number: 3008881809-2024-00052
• Device Sequence Number: 7271308
• Product Code: HCG
• UDI-Device Identifier: 07613327128260
• UDI-Public: 07613327128260
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2025
• Device Catalogue Number: M0036122060
• Device Lot Number: 23414482
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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: AXS INFINITY (STRYKER); NEUROFORM ATLAS (STRYKER); SYNCHRO14 GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White