MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035423060

Device Problems Migration (4003); Premature Separation (4045)

Patient Problem Occlusion (1984)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during procedure by coiling an anterior communicating artery (acom) aneurysm, the coil (subject device) did not detach.After multiple attempts to detach the coil, the physician decided to pull back the coil in the middle of microcatheter and part of the coil remained in the aneurysm.Later on, the proximal part of the coil migrated from the catheter and occluded the anterior cerebral artery (aca).There were no medical consequences to the patient.

Manufacturer Narrative

Based on the results of the dhr (device history record), there is no indication that the device, labelling or packaging failed to meet its specifications when released.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed; 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 patient vessel occlusion while anticipated in nature as per the dfu is likely to be due to the main coil damage.While there are several potential causes for the reported issues, because review and analysis of available information failed to identify a definitive cause, and because the device was not returned a cause of undeterminable was assigned.

Event Description

It was reported that during procedure by coiling an anterior communicating artery (acom) aneurysm, the coil (subject device) did not detach.After multiple attempts to detach the coil, the physician decided to pull back the coil in the middle of microcatheter and part of the coil remained in the aneurysm.Later on, the proximal part of the coil migrated from the catheter and occluded the anterior cerebral artery (aca).There were no medical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 6CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8388721
• MDR Text Key: 137788936
• Report Number: 3008881809-2019-00063
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: 04546540675880
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Catalogue Number: M0035423060
• Device Lot Number: 20785800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROCATHETER (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Other
• Patient Age: 82 YR