MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421530
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm embolization case, the operator used a microcatheter to place the first coil.When placing the second coil, the operator reported that the delivery force was missing and confirmed that the coil was stretched.The operator withdrew the microcatheter and second coil and the first coil was unexpectedly removed, as it was tangled with the second coil.The operator replaced the microcatheter with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during an aneurysm embolization case, the operator used a microcatheter to place the first coil.When placing the second coil, the operator reported that the delivery force was missing and confirmed that the coil was stretched.The operator withdrew the microcatheter and second coil and the first coil was unexpectedly removed, as it was tangled with the second coil.The operator replaced the microcatheter 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 due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the main coil was found to be detached.As per the event description, the coil was detached but then tangled with other coil and pulled out.The coil delivery wire was found to be kinked/bent.The main coil was found to be stretched and kinked/bent.Functional inspection of the following reported defects was not performed: main coil migration functional test and device interaction with another device as it was not applicable and main coil tangled, as the defect was not confirmed during visual inspection.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 reported main coil migration and device interaction with another device could not be replicated during the analysis; however, the analysis results are consistent with the reported event.The reported main coil tangled was not confirmed during the analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition prior to use on the patient, continuous flush was set up and maintained and the patient¿s anatomy was described as 'moderately torturous'.During analysis, the main coil was found to be stretched and kinked/bent.It was stated in the event description that the coil was detached and implanted but then tangled to the other coil and pulled out.The coil returned in deployment state (confirmed it was electrical deployment).Based on this information the reported coil migration was confirmed during the analysis.The coil delivery wire was found to be kinked/bent.An assignable cause of procedural factors will be assigned to the reported and analysed defects 'main coil migration¿, ¿device interaction with another device' and to the analysed defects ¿main coil kinked/bent¿, ¿main coil stretched¿ and ¿coil delivery wire kinked/bent¿ as these defects are 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.It is probable that the moderately tortuous anatomy may have caused damages to the device and the reported event during use.An assignable cause of not confirmed will be assigned to the reported defect 'main coil tangled' as the defect was not confirmed during the analysis.

• Brand Name: TARGET 360 NANO 1.5MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17116341
• Report Number: 3008881809-2023-00297
• Device Sequence Number: 12405766
• Product Code: HCG
• UDI-Device Identifier: 04546540697943
• UDI-Public: 04546540697943
• 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): 08/01/2023

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: 06/19/2025
• Device Model Number: M0035421530
• Device Catalogue Number: M0035421530
• Device Lot Number: 23705958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TARGET COIL (STRYKER).; XT-17 MICROCATHETER (STRYKER).
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Race: Asian