MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during posterior communicating artery (pcom) aneurysm embolization procedure, the subject coil was delivered via the microcatheter into the aneurysm.At some point, the subject coil was not able to advance and not fully inserted into the aneurysm.The next step was to withdraw the whole subject coil into the microcatheter.Upon withdrawn, the subject coil was stretched and was noted to be broken into two parts.Most of the subject coil was withdrawn with the microcatheter but the broken/stretched distal part of the subject coil remained inside the patient¿s vessel.It was observed that the thin fiber rolled to a "ball of fibers" and this ball was removed successfully with a snare device.Patient was set under ass and is stable.
Additional Manufacturer Narrative
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 returned for analysis; therefore, physical as well as a functional testing could not be performed.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 device was not returned and therefore the as reported cannot be confirmed.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 will be assigned to this complaint.
Event or Problem Description
It was reported that during posterior communicating artery (pcom) aneurysm embolization procedure, the subject coil was delivered via the microcatheter into the aneurysm.At some point, the subject coil was not able to advance and not fully inserted into the aneurysm.The next step was to withdraw the whole subject coil into the microcatheter.Upon withdrawn, the subject coil was stretched and was noted to be broken into two parts.Most of the subject coil was withdrawn with the microcatheter but the broken/stretched distal part of the subject coil remained inside the patient¿s vessel.It was observed that the thin fiber rolled to a "ball of fibers" and this ball was removed successfully with a snare device.Patient was set under ass and is stable.

• Brand Name: TARGET XL 360 SOFT 10MM X 40CM
• 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: 14569647
• Report Number: 3008881809-2022-00259
• Device Sequence Number: 6085042
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: 07613327004601
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/25/2022

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: 10/07/2023
• Device Model Number: M0036121040
• Device Catalogue Number: M0036121040
• Device Lot Number: 22474541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• 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: SL-10 MICROCATHETER (STRYKER); TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female