MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181650
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the coil (subject device) prematurely detached from the delivery wire in the internal carotid artery (ica) while being deployed.The delivery wire was removed from the patients body.The coil was not fully deployed in the aneurysm so the physician used a stent to tack down the coil tail to keep it in place and to complete the procedure successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the coil (subject device) prematurely detached from the delivery wire in the internal carotid artery (ica) while being deployed.The delivery wire was removed from the patients body.The coil was not fully deployed in the aneurysm so the physician used a stent to tack down the coil tail to keep it in place and to complete the procedure successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.D9 product available to stryker- updated.D9 returned to manufacturer on- updated.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.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 delivery wire was seen to be kinked/bent and the main coil was seen to be detached/separated.The main coil and introducer sheath were not returned.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 failed to meet specifications when received for complaint investigation based on the analysed anomalies noted to the device.The device was analysed.During analysis, the delivery wire was seen to be kinked/bent and the main coil was seen to be detached from the delivery wire, and not returned.Additional information provided by the customer indicated that the coil deployment was interrupted and the coil broke off prematurely at the detachment zone in the internal carotid artery (ica), the coil could not be fully deployed without the use of a stent to tack it down.An assignable cause of procedural factors was assigned to the as reported/as analyzed defect main coil prematurely detached/separated during use as 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 factors during use.An assignable cause of handling damage was assigned to the as analyzed defects coil delivery wire kinked/bent as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: TARGET XXL 360 16MM X 50CM
• 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: 16268569
• Report Number: 3008881809-2023-00047
• Device Sequence Number: 6390793
• Product Code: HCG
• UDI-Device Identifier: 07613327128352
• UDI-Public: 07613327128352
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161429
• 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): 03/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2023
• Device Model Number: M0036181650
• Device Catalogue Number: M0036181650
• Device Lot Number: 22638430
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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: STENT (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female