MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035452040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Rupture (2208)
Date of Event	04/23/2019
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 procedure for coil embolization located in the left middle cerebral artery (mca) aneurysm, when advancing the subject coil out of microcatheter, the digital subtraction angiography (dsa) showed the subject coil was bigger than it should be, and it perforated the aneurysm.Thus, the operator immediately detached the subject coil inside the patient¿s aneurysm and used other brand coils to finish the embolization completely.There were no clinical consequences to the patient due to the reported event and the patient¿s current condition is good.
Event or Problem Description
It was reported that during procedure for coil embolization located in the left middle cerebral artery (mca) aneurysm, when advancing the subject coil out of microcatheter, the digital subtraction angiography (dsa) showed the subject coil was bigger than it should be, and it perforated the aneurysm.Thus, the operator immediately detached the subject coil inside the patient¿s aneurysm and used other brand coils to finish the embolization completely.There were no clinical consequences to the patient due to the reported event and the patient¿s current condition is good.
Additional Manufacturer Narrative
The edhr (electronic device history record) for the device lot is created and maintained in mes (manufacturing execution system).Automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The target nano coil design control and compliance has and continues to be maintained to provide verified and validated coils sized to fit the as labelled aneurysm dimensions.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The reported events are covered in the device directions for use.The risks of the reported events are documented in the risk documentation and there are current controls to mitigate the risk of the as reported events.No anomalies were noted to the device prior to use and there is no indication of a use error.As this device was not returned for analysis review of available information failed to identify a definitive cause, therefore an assignable cause of undeterminable will be assigned to the reported event.

• Brand Name: TARGET HELICAL NANO 2 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8570275
• Report Number: 3008881809-2019-00115
• Device Sequence Number: 1537269
• Product Code: HCG
• UDI-Device Identifier: 07613252600374
• UDI-Public: 07613252600374
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 05/31/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2021
• Device Catalogue Number: M0035452040
• Device Lot Number: 21040402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICROCATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 78