MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036127200
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the subject device was implanted.
Event or Problem Description
It was reported that the patient who underwent a coil embolization for the treatment of an aneurysm located in the basilar apex.The target aneurysm was unruptured and saccular, located in the basilar apex with dome height of 7.1 mm, dome width of 10.6 mm, dome depth of 9.1 mm, and neck width of 5.6 mm.The dome to neck ratio was 1.89.The parent vessel diameter was 4.6 mm proximal to the aneurysm neck and 4.6 mm distal to the aneurysm neck.The index procedure was performed, and the subject coil was successfully deployed.The subject coil herniation was noticed at 6-month visit angiogram and the medication was administered to the patient.The subject is doing well.
Event or Problem Description
It was reported that the patient who underwent a coil embolization for the treatment of an aneurysm located in the basilar apex.The target aneurysm was unruptured and saccular, located in the basilar apex with dome height of 7.1 mm, dome width of 10.6 mm, dome depth of 9.1 mm, and neck width of 5.6 mm.The dome to neck ratio was 1.89.The parent vessel diameter was 4.6 mm proximal to the aneurysm neck and 4.6 mm distal to the aneurysm neck.The index procedure was performed, and the subject coil was successfully deployed.The subject coil herniation was noticed at 6-month visit angiogram and the medication was administered to the patient.The subject is doing well.
Additional 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 that the target coil herniation was noticed at 6-month visit angiogram.This event was not associated with any adverse event.There was no device related issues noted during the initial procedure.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.

• Brand Name: TARGET XL 360 SOFT 7MM X 20CM
• 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: 18858150
• Report Number: 3008881809-2024-00098
• Device Sequence Number: 19667619
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: 07613327004632
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2025
• Device Catalogue Number: M0036127200
• Device Lot Number: 24049292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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: MICROCATHETER 1018 DEVICE (STRYKER).
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Race: White