MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035475200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

This is 2 of 2 reports (2nd mdr).

Event Description

It was reported that during c6 aneurysm case.Used stryker catheter to deliver the stent to half-deploy, delivered coils and then deployed the stent completely.At the same time inserted the last coil (subject device) with crossing technique but the stent got stuck at tip of catheter used and the coil (subject device) stuck at tip of catheter.The products could not be withdrawn so the operator used a balloon to get the stent and the coil (subject device) back and prepared to arrange another surgery to do the embolization.Patient was sent back home and waiting for next surgery.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

This is 2 of 2 reports (2nd mdr).Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was found to be severely kinked/bent in multiply areas, the main coil was found to be intact, and the coil introducer sheath was found to be intact.A functional inspection was unable to perform the test due to device damages.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 association of the patient medical or surgical intervention required to the coil jammed is unclear from the complaint information and additional information, so potential severity could not be assest.The reported coil jammed could not be replicated; however, the analysis results are consistent with the reported event.The reported patient medical or surgical intervention could not be confirmed during the analysis as it is patient/procedure related issue, and the information received are unclear.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed.The main coil was found to be intact.The coil delivery wire was found to be severely kinked/bent in multiply areas.It is very probable that this defect may have caused the reported issue.An assignable cause of procedural factors will be assigned to the as reported 'coil jammed', and to the as analyzed code 'coil delivery wire kinked/bent' 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 undeterminable will be assigned to the as reported 'patient medical or surgical intervention required' as the analysis results and review of all available information fails to indicate an assignable cause or probable assignable cause for the reported event.

Event Description

It was reported that during c6 aneurysm case.Used stryker catheter to deliver the stent to half-deploy, delivered coils and then deployed the stent completely.At the same time inserted the last coil (subject device) with crossing technique but the stent got stuck at tip of catheter used and the coil (subject device) stuck at tip of catheter.The products could not be withdrawn so the operator used a balloon to get the stent and the coil (subject device) back and prepared to arrange another surgery to do the embolization.Patient was sent back home and waiting for next surgery.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 5MM X 20CM
• Type of Device: 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: 16899880
• MDR Text Key: 314884548
• Report Number: 3008881809-2023-00235
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: 04546540676511
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0035475200
• Device Catalogue Number: M0035475200
• Device Lot Number: 23741148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EZ STENT (STRYKER); METRONIC COIL (NON-STRYKER); SL-10 CATHETER (STRYKER); TARGET COILS (STRYKER); XT-27 CATHETER (STRYKER)
• Patient Outcome(s): Required Intervention