MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coil embolization procedure of an unruptured aneurysm, the operator attempted to deliver the subject coil as the third coil to the target lesion.The subject coil and the microcatheter were adjusted several times due to tortuosity and stenosis of the patients vascular anatomy.The subject coil got prematurely detached in the microcatheter and was discontinued to use.The subject coil was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the coil was returned detached within a microcatheter.The main coil was seen to be kinked.Functional inspection: the catheter was flushed and a patency mandrel was advanced through to remove the coil.The main coil exited the distal of the catheter.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 failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.The reported complaint was confirmed based on analysis.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use, the device was prepared as per the dfu.Also additional information indicated that the patient anatomy was severely torturous which would have contributed to the event.The returned main coil was found to be detached.Therefore the as reported 'main coil prematurely detached/separated during use' can be confirmed.The as reported and as analyzed 'main coil prematurely detached/separated during use' as well as the 'main coil kinked/bent' will be assigned procedural factors as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during a coil embolization procedure of an unruptured aneurysm, the operator attempted to deliver the subject coil as the third coil to the target lesion.The subject coil and the microcatheter were adjusted several times due to tortuosity and stenosis of the patients vascular anatomy.The subject coil got prematurely detached in the microcatheter and was discontinued to use.The subject coil was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL NANO 1MM X 3CM
• 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: 12747166
• Report Number: 3008881809-2021-00467
• Device Sequence Number: 4530203
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: 04546540698018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/18/2022

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: 04/06/2024
• Device Model Number: M0035431030
• Device Catalogue Number: M0035431030
• Device Lot Number: 22837947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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); EXCELSIOR XT-17 MICROCATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR XT-17 MICROCATHETER (STRYKER)
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Race: Asian