MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that a procedure was done in the right middle cerebral artery (mca) m1 segment bifurcation for an aneurysm sized 6.2mm by 6.8mm.Physician used the subject coil and while adjusting encountered resistance.The subject coil was retracted and its distal portion was broken.The subject coil fragment was completely removed from the patient¿s anatomy without a snare.Digital subtraction angiography (dsa) showed presence of an unstable thrombus in the aneurysm, so physician used urokinase for thrombolysis.After 10 min, the thrombus had completely resolved.Considering the safety of the procedure, the physician decided to do another surgery later.It was reported that the patient had unknown clinical consequences due to the event.One month later, an unknown retreatment procedure was completed successfully.No other information is available.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection indicated that the proximal contact wire was intact.The coil delivery wire was kinked/bent.The distal tip was found to be intact.The main coil was intact.The main coil was damaged during analysis when it became knotted.Functional inspection indicated that coil friction in catheter test - pass.The device was flushed and advanced in a demonstration sl-10 catheter without any resistance felt.The reported defect was not confirmed during analysis.The as analyzed defects coil delivery wire kinked/bent will be assigned to this investigation.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.An assignable cause of anticipated procedural complication, will be assigned to the reported issue of patient vessel thrombosis and patient medical or surgical intervention required, as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.The as reported main coil broken/fractured during use was not confirmed during analysis.An assignable cause of not confirmed will be assigned to the reported main coil broken/fractured during use, as the main coil was not broken or fractured.The delivery wire was seen to be kinked/bent which may have caused friction in the catheter.The as reported coil in catheter friction and as analyzed coil delivery wire kinked bent will be assigned handling damage 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.
Event or Problem Description
It was reported that a procedure was done in the right middle cerebral artery (mca) m1 segment bifurcation for an aneurysm sized 6.2mm by 6.8mm.Physician used the subject coil and while adjusting encountered resistance.The subject coil was retracted and its distal portion was broken.The subject coil fragment was completely removed from the patient¿s anatomy without a snare.Digital subtraction angiography (dsa) showed presence of an unstable thrombus in the aneurysm, so physician used urokinase for thrombolysis.After 10 min, the thrombus had completely resolved.Considering the safety of the procedure, the physician decided to do another surgery later.It was reported that the patient had unknown clinical consequences due to the event.One month later, an unknown retreatment procedure was completed successfully.No other information is available.

• Brand Name: TARGET 360 SOFT 6MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10868959
• Report Number: 3008881809-2020-00351
• Device Sequence Number: 19584690
• Product Code: HCG
• UDI-Device Identifier: 04546540676542
• UDI-Public: 04546540676542
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/07/2021

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: 12/01/2022
• Device Model Number: M0035476200
• Device Catalogue Number: M0035476200
• Device Lot Number: 21983294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICRO CATHETER(STRYKER); SYNCHRO2 GUIDEWIRE(STRYKER); SL-10 MICRO CATHETER(STRYKER); SYNCHRO2 GUIDEWIRE(STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR