MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035475150
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); No Code Available (3191)
Date of Event	09/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimension and functional testing could not be performed.In case of this complaint, it is possible that the main coil encountered friction and was stretched during repositioning due to some procedural factors encountered during use due to which vertebral sacrifice had to be performed and medical intervention was required, possibly leading to as reported issues 'nv ¿ main coil stretched', 'nv ¿ coil in catheter friction' and 'nv ¿ patient medical intervention required'; however, it could not be confirmed.As per the additional information provided, no damage was noted to the device prior to use and the device was prepared as per direction for use (dfu) for this product.As assignable cause of undeterminable was assigned to the reported issues, as the device was not returned, and the review and analysis of all available information failed to indicate an assignable cause.
Event or Problem Description
It was reported that during coil embolization for a ruptured aneurysm for a patient that was in a poor clinical condition (hunt and hess grade 5), the subject coil was stretched when repositioned.Due to the stretched coil, a vertebral sacrifice had to be performed.No additional information is available at this time.
Event or Problem Description
It was reported that during coil embolization for a patient that was in a poor clinical condition ( hunt and hess grade 5), the subject coil was stretched when repositioned.The ruptured aneurysm was located at the basilar artery and the subject coil was protruded from the aneurysm.Due to the stretched coil and thrombus formation, a vertebral sacrifice had to be performed by coil embolization.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimension and functional testing could not be performed.In case of this complaint it is possible that the main coil encountered friction and was stretched during repositioning due to some procedural factors encountered during use due to which vertebral sacrifice had to be performed and medical intervention was required, possibly leading to the as reported issues.Based on the investigation results and available information an assignable cause of anticipated procedural complication was assigned to the as reported issues 'nv - patient thrombosis (treated vessel) ' and 'nv - patient vessel perforation', since the issues are due to a known physiological effect of the procedure and/or patient condition noted with the direction for use, device labeling and/or risk documentation files.As per the additional information provided by the customer, no damage was noted to the device prior to use and the device was prepared as per direction for use (dfu); therefore, an assignable cause of undetermined was assigned to the as reported issues 'nv main coil stretched', 'nv - patient medical intervention required', and 'nv coil in catheter friction', as the device was not returned, and the review and analysis of all available information failed to indicate as assignable cause.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, it is possible that the main coil encountered friction and stretched during repositioning due to some procedural factors encountered during use and later protruded due to which a vertebral sacrifice had to be performed and medical intervention was required, possibly leading to as reported issues.Based on the investigation results and available information as assignable cause of anticipated procedural complication was assigned to the as reported issue ' nv- patient thrombosis (treated vessel)', since the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, device labelling and/or risk documentation files.As per additional information no damage was noted to the device prior to use and the device was prepared as per dfu for this product.An assignable cause of undetermined was assigned to the as reported issues 'nv - main coil stretched', 'nv - patient medical intervention required', 'nv - coil in catheter friction', 'nv - main coil protrusion', as the device was not returned, and the review and analysis of all available information failed to indicate an assignable cause.As reported code nv- patient vessel perforation was updated to nv- main coil protrusion.
Event or Problem Description
It was reported that during coil embolization for a patient that was in a poor clinical condition ( hunt and hess grade 5), the subject coil was stretched when repositioned.The ruptured aneurysm was located at the basilar artery and the subject coil was protruded from the aneurysm.Due to the stretched coil and thrombus formation, a vertebral sacrifice had to be performed by coil embolization.

• Brand Name: TARGET 360 SOFT 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8017629
• Report Number: 3008881809-2018-00467
• Device Sequence Number: 19177894
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: 04546540676504
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2019

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: 01/31/2021
• Device Catalogue Number: M0035475150
• Device Lot Number: 20232226
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/31/2018; 12/13/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/27/2018; 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention