MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035424150

Device Problem Fracture (1260)

Patient Problem Coma (2417)

Event Date 02/21/2022

Event Type  Injury  

Event Description

It was reported that a right pcoma (posterior communicating artery) aneurysm embolization procedure was performed in a female patient with right pcoma (posterior communicating artery) dissection aneurysm.During the procedure the physician used a guidewire to bring a microcatheter to reach the aneurysm and prepared to fill the subject coil.After delivered half of the subject coil into aneurysm, the subject coil was not able to be advanced any more.The physician then tried to retract the subject coil delivery wire, but found the subject coil got fractured and part of the subject coil was inside the patient's vascular anatomy.The physician shaped a guidewire and used the guidewire as a snare device to retrieve the subject coil out by entwining the subject coil with the shaped guidewire.When the physician delivered the guidewire into patient's body for several minutes and checked under fluoroscopy, the physician found the guidewire tip was not moved and when withdrew the guidewire, the physician found that the guidewire was fractured and was left inside patient's vascular anatomy.Finally, the physician decided to perform a craniotomy procedure to take the fractured coil out and used a retriever stent to remove the fractured guidewire from the patient's vascular anatomy.The procedure was then suspended because of the reported issue and medical intervention was provide to the patient.180 minutes of surgical delay was noted.Inpatient hospitalization or prolongation of existing hospitalization was noted.The aneurysm coil embolization was not completed during the same procedure.12 hours after the procedure, the patient was still in coma.No further information is available.

Event Description

It was reported that a right pcoma (posterior communicating artery) aneurysm embolization procedure was performed in a female patient with right pcoma (posterior communicating artery) dissection aneurysm.During the procedure the physician used a guidewire to bring a microcatheter to reach the aneurysm and prepared to fill the subject coil.After delivered half of the subject coil into aneurysm, the subject coil was not able to be advanced any more.The physician then tried to retract the subject coil delivery wire, but found the subject coil got fractured and part of the subject coil was inside the patient's vascular anatomy.The physician shaped a guidewire and used the guidewire as a snare device to retrieve the subject coil out by entwining the subject coil with the shaped guidewire.When the physician delivered the guidewire into patient's body for several minutes and checked under fluoroscopy, the physician found the guidewire tip was not moved and when withdrew the guidewire, the physician found that the guidewire was fractured and was left inside patient's vascular anatomy.Finally, the physician decided to perform a craniotomy procedure to take the fractured coil out and used a retriever stent to remove the fractured guidewire from the patient's vascular anatomy.The procedure was then suspended because of the reported issue and medical intervention was provide to the patient.180 minutes of surgical delay was noted.Inpatient hospitalization or prolongation of existing hospitalization was noted.The aneurysm coil embolization was not completed during the same procedure.12 hours after the procedure, the patient was still in coma.No further information is available.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the coil delivery wire was found to be kinked/bent.The main coil was found to be broken/fractured.The coil was not returned.Functional inspection: coil in catheter friction functional test ¿ unable to perform as the coil was found to be detached.Main coil broken/fractured during use functional test ¿ n/a.Patient neurological deficit functional test ¿ n/a.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 coil in catheter friction could not be confirmed; however, the analysis results are consistent with the reported event.The reported main coil broken/fractured was confirmed during the analysis.The reported patient neurological deficit could not be confirmed during the analysis as the event is patient related.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The returned device was analyzed.The main coil was found to be broken/fractured and not returned.The coil delivery wire was found to be kinked/bent.An assignable cause of procedural factors will be assigned to the reported 'coil in catheter friction', 'patient neurological deficit', and 'main coil broken/fractured', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.A probable cause of handling damage was 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 the procedure.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• 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: 13831806
• MDR Text Key: 287670791
• Report Number: 3008881809-2022-00127
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: M0035424150
• Device Catalogue Number: M0035424150
• Device Lot Number: 22752862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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: ECHELON 10 MICROCATHETER (MEDTRONIC); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Outcome(s): Required Intervention; Other; Life Threatening; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: Asian