MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036128300
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
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 left middle cerebral artery (mca) aneurysm embolization case, subject coil got stretched while repositioning it near target lesion.This stretched subject coil was retrieved from patient¿s body using a snare device as medical intervention.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.
Event or Problem Description
It was reported that during left middle cerebral artery (mca) aneurysm embolization case, subject coil got stretched while repositioning it near target lesion.This stretched subject coil was retrieved from patient¿s body using a snare device as medical intervention.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.
Additional Manufacturer Narrative
D4 expiration date - added.D9 / h3 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.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 and microscopic inspection, it was observed that the subject coil delivery wire was seen to be kinked in two locations and the subject main coil was seen to be severely stretched and fractured along with the suture damaged.The introducer sheath was not returned.Functional testing could not be performed due to damage to subject coil and reported event was confirmed based on 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 as reported code main coil stretched was confirmed during analysis and as reported code patient medical or surgical intervention required could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During device analysis, the subject coil delivery wire was seen to be kinked/bent and the main coil was seen to be stretched, broken/fractured and suture was also noticed damage.An assignable cause of procedural factors will be assigned to the as reported patient medical or surgical intervention required, main coil stretched 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.An assignable cause of handling damage will be assigned to the as analyzed coil delivery wire kinked/bent as the defect appears to be associated with handling of the product or portion of the product during preparation.An assignable cause of procedural factors will be assigned to the as analyzed codes main coil broken/fractured during use, main coil stretched and main coil suture damage 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 8MM X 30CM
• 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: 19018126
• Report Number: 3008881809-2024-00141
• Device Sequence Number: 4021148
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• 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): 07/12/2024

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: 11/23/2024
• Device Catalogue Number: M0036128300
• Device Lot Number: 23301474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN).; SNARE DEVICE (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown