MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036122030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject coil was guided into the patient anatomy.Physician felt resistance while repositioning the subject coil to engage to the vessel.After confirming that the subject coil had settled within the target lesion, physician started to detach the subject coil and slowly pulled the delivery wire and it was found that the subject coil was stretched.A snare device was used to retrieve the subject coil from the patient anatomy.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, the subject coil was guided into the patient anatomy.Physician felt resistance while repositioning the subject coil to engage to the vessel.After confirming that the subject coil had settled within the target lesion, physician started to detach the subject coil and slowly pulled the delivery wire and it was found that the subject coil was stretched.A snare device was used to retrieve the subject coil from the patient 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 d10 product available to stryker ¿ updated d10 returned to manufacturer on ¿ updated due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the coil delivery wire was not returned.The main coil was seen to be stretched and kinked.Functional inspection was not applicable as defect was confirmed.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 complaint was confirmed based on analysis.The device met specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed and the coil delivery wire was not returned.The main coil was found to be stretched and kinked.It is unknown if flush set up and maintained throughout the clinical procedure.An assignable cause of procedural factors will be assigned to the as reported ¿main coil stretched¿, ¿device difficult engaging target vessel¿ and ¿patient medical or surgical intervention required' as well as analyzed ¿main coil stretched¿ and ¿ main coil kinked/bent¿, as these defects 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 factors during use.

• Brand Name: TARGET XL 360 SOFT 2MM 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: 16856987
• Report Number: 3008881809-2023-00221
• Device Sequence Number: 8576164
• Product Code: HCG
• UDI-Device Identifier: 07613327128321
• UDI-Public: 07613327128321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/21/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2024
• Device Model Number: M0036122030
• Device Catalogue Number: M0036122030
• Device Lot Number: 23132444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown