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

Model Number	M0035476300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure for right mca (middle cerebral artery) aneurysm, a coil (subject device) was delivered into lumen of aneurysm with the help of a microcatheter and a guidewire.During the delivery of the subject coil, it got stretched after it just went into lumen of aneurysm.It was reported that the coil was advanced with force inside the microcatheter.When the physician withdrew the subject coil to check it, the subject coil was separated from its delivery wire.The prematurely detached subject coil was removed successfully from the patient's anatomy through the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure for right mca (middle cerebral artery) aneurysm, a coil (subject device) was delivered into lumen of aneurysm with the help of a microcatheter and a guidewire.During the delivery of the subject coil, it got stretched after it just went into lumen of aneurysm.It was reported that the coil was advanced with force inside the microcatheter.When the physician withdrew the subject coil to check it, the subject coil was separated from its delivery wire.The prematurely detached subject coil was removed successfully from the patient's anatomy through the microcatheter.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 delivery wire was found to be kinked/bent but the delivery wire proximal contact was found to be intact.The main coil was found to be detached from the delivery wire.Functional inspection was unable to perform the test as the main coil wasn¿t returned.The reported defect main coil prematurely separated/detached during use was confirmed during analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.It was not possible to confirm if the main coil was stretched as the main coil was not returned for 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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained during the clinical procedure.Based on the investigation, this complaint appears to be associated with a product that met stryker 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.Therefore, an assignable cause of procedural factors will be assigned to the as reported and as analyzed event of main coil prematurely separated/detached during use and to the as reported main coil stretched.An assignable cause of handling damage will be assigned to the as analyzed event coil delivery wire kinked/bent as it is most likely that the delivery wire damage occurred due to handling of the device during use.

• 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: 11720850
• Report Number: 3008881809-2021-00177
• Device Sequence Number: 3309219
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: 04546540676559
• 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): 07/16/2021

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: 10/09/2022
• Device Model Number: M0035476300
• Device Catalogue Number: M0035476300
• Device Lot Number: 21815859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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: AXS CATALYST CAT5 CATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COILS (STRYKER); UNKNOWN 6F 90CM CATHETER; UNKNOWN 8F ARTERY SHEATH
• Patient Age: 69 YR