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

Model Number	M0035431010
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to the manufacturer yet.
Event or Problem Description
It was reported that during ruptured aneurysm coil embolization procedure, the subject coil prematurely detached at the posterior communicating artery(pcomm) inside the aneurysm before the physician put the detacher on the delivery wire of the coil.The subject coil remained implanted inside the aneurysm.The physician removed the delivery wire/proximal coil and completed the procedure successfully.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added d10 product available to stryker - updated h3 device evaluated by mfg - updated h3 summary attached - updated 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 was returned and the lot number was confirmed with the packaging.Visual analysis revealed that the subject coil was returned attached to the delivery wire, the proximal contact wire was intact, the coil delivery wire was kinked/bent, the distal tip was found to be intact and the main coil was stretched.Functional test was not required as the reported defect was not confirmed during visual analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.Therefore, the as reported 'main coil prematurely detached/separated during use' was not confirmed.In the case of this complaint it is most likely that the coil stretched during coil advancement against friction.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will be assigned to 'main coil stretched'.An assignable cause of 'handling damage' will be assigned to 'coil delivery wire kinked/bent' as it is most likely that the delivery wire kinked due to handling of the device during use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during ruptured aneurysm coil embolization procedure, the subject coil prematurely detached at the posterior communicating artery(pcomm) inside the aneurysm before the physician put the detacher on the delivery wire of the coil.The subject coil remained implanted inside the aneurysm.The physician removed the delivery wire/proximal coil and completed the procedure successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 1MM X 1CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9649363
• Report Number: 3008881809-2020-00026
• Device Sequence Number: 2907992
• Product Code: HCG
• UDI-Device Identifier: 04546540700216
• UDI-Public: 04546540700216
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/26/2020

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: 08/19/2022
• Device Model Number: M0035431010
• Device Catalogue Number: M0035431010
• Device Lot Number: 21681109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/18/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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: ECHELON 10 MICROCATHETER(MEDTRONIC)