MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that endovascular coiling of anterior communicating artery (a com) aneurysm was performed in a patient.During the procedure initially guide catheter and microcatheter were used to reach the target lesion, when attempted to deliver the subject coil to the target lesion, the subject coil detached prematurely and got stretched inside the lumen of the microcatheter.The subject coil was retracted out of the patient's vascular anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.Additional information provided by the customer indicated that the subject coil was inspected prior to use, no issues were noticed, and a microcatheter was used with the subject coil.While there are a number of potential causes for the reported issue of main coil prematurely detached/separated during use and main coil stretched, 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 to this complaint reported for main coil prematurely detached/separated during use and main coil stretched.
Event or Problem Description
It was reported that endovascular coiling of anterior communicating artery (a com) aneurysm was performed in a patient.During the procedure initially guide catheter and microcatheter were used to reach the target lesion, when attempted to deliver the subject coil to the target lesion, the subject coil detached prematurely and got stretched inside the lumen of the microcatheter.The subject coil was retracted out of the patient's vascular anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 3MM 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: 12882795
• Report Number: 3008881809-2021-00495
• Device Sequence Number: 17134060
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 02/24/2022

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: 04/10/2024
• Device Model Number: M0035443060
• Device Catalogue Number: M0035443060
• Device Lot Number: 22847479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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: EXCELSIOR - SL- 10 MICROCATHETER (STRYKER); GUIDER 6F GUIDE CATHETER (STRYKER)
• Patient Sex: Male