MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476300
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject coil prematurely detached and protruded out of the aneurysm.The physician used a coronary balloon catheter as medical intervention to press the subject coil against the guide catheter and fully remove the entire system from the patient anatomy.The procedure was completed successfully with a different device and without clinical consequence to the patient.Patient underwent prolonged hospital stay due to unknown reasons as event was successfully resolved.
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.The device was returned.The lot number was confirmed with the packaging returned with the device.On visual & microscope inspection, the proximal contact wire was intact.The coil delivery wire was severely kinked/bent.The main coil was detached.The distal tip was found to be intact.The main coil was stretched.Functional testing was not required as the reported defect was confirmed during analysis.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 damage noted to the device would be indicative of the as reported defect.An assignable cause of procedural factors will be assigned to the as analyzed/as reported main coil prematurely detached/separated during use and as reported main coil protrusion and as analyzed main coil stretched, 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 the procedure, the subject coil prematurely detached and protruded out of the aneurysm.The physician used a coronary balloon catheter as medical intervention to press the subject coil against the guide catheter and fully remove the entire system from the patient anatomy.The procedure was completed successfully with a different device and without clinical consequence to the patient.Patient underwent prolonged hospital stay due to unknown reasons as event was successfully resolved.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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: 11128632
• Report Number: 3008881809-2021-00011
• Device Sequence Number: 3334759
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: 04546540676559
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 11/10/2022
• Device Model Number: M0035476300
• Device Catalogue Number: M0035476300
• Device Lot Number: 21920276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/12/2021
• 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: ECHELON CATHETER (UNKNOWN); ECHELON CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR