MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the coil (subject device) couldn't be detached inside the aneurysm and during re-positioning, it got detached prematurely inside the patient's anatomy.A snare device was used to remove the detached coil from the patient's anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the proximal contact wire was intact and the coil delivery wire was found kinked/bent.The main coil appeared to be electrolytically detached and not returned.Unable to carry out the functional as the coil was detached and not returned.The reported complaint was confirmed based on 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.It was reported that the coil (subject device) detached prematurely during the procedure and a snare device was used to remove the detached coil from the patient's anatomy.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the patient's anatomy was not tortuous.Based on visual inspection, it appears the main coil had been electrolytically detached.In the case of this complaint, it is probable that the coil was partially detached following attempted electrolytic detachment with the inzone.It is likely that the coil then fully detached due to manipulation when attempting to reposition it outside the aneurysm.Based on the investigation, an assignable cause of procedural factors will be assigned to the as reported and as analyzed main coil prematurely detached/separated during use since this issue appears to be associated with a product that met design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the coil delivery wire kinked/bent and main coil failed/unable to detach since the coil delivery wire was likely kinked from handling and as a result this caused the failed detachment attempt with the inzone.
Event or Problem Description
It was reported that the coil (subject device) couldn't be detached inside the aneurysm and during re-positioning, it got detached prematurely inside the patient's anatomy.A snare device was used to remove the detached coil from the patient's anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11208504
• Report Number: 3008881809-2021-00043
• Device Sequence Number: 3544991
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• 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): 03/03/2021

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: 07/06/2023
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 22327952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 03/03/2021
• 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: INZONE POWER SUPPLY (STRYKER); INZONE POWER SUPPLY (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 60