MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a procedure for a mca (middle cerebral artery) wide-necked aneurysm sized 3.4mm 4.3mm, physician delivered microcatheters under guiding of guidewire to right mca m2 segment.Physician then used coils to begin filling aneurysm.Dsa (digital subtraction angiography) showed the aneurysm was partially embolized and physician then proceeded to deliver stent to cover neck of aneurysm.Upon filling with subject coil, big resistance was encountered and could not be delivered out of microcatheter.Physician proceeded to remove subject and noted that the coil had broken and the tail was stretched.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Device was returned for analysis and the reported lot number was confirmed from the packaging label.During visual inspection, the subject coil delivery wire was bent and the subject main coil was stretched.Functional testing was unable to be performed due to the damage noted.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 main coil broken/fractured during use was not confirmed based on analysis.The damage noted to the device would be indicative of the as reported defect.The as reported coil in catheter friction and as reported/as analyzed main coil stretched will be assigned procedural factors as the defect appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.It can be presumed that the delivery wire was damaged during the procedure as force may have been applied when the friction was felt.Because this defect appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use, a probable cause of handling damage will be assigned to the as analyzed coil delivery wire kinked/bent.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported during a procedure for a mca (middle cerebral artery) wide-necked aneurysm sized 3.4mm*4.3mm, physician delivered microcatheters under guiding of guidewire to right mca m2 segment.Physician then used coils to begin filling aneurysm.Dsa (digital subtraction angiography) showed the aneurysm was partially embolized and physician then proceeded to deliver stent to cover neck of aneurysm.Upon filling with subject coil, big resistance was encountered and could not be delivered out of microcatheter.Physician proceeded to remove subject and noted that the coil had broken and the tail was stretched.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Analysis of the returned device revealed that the subject coil was not broken/fractured during use; therefore, based on this information the event is deemed non-reportable with the new awareness date of 30-dec-2020.The pi will be re assessed to reflect the decision change and emdr will be filed accordingly.

• Brand Name: TARGET HELICAL NANO 1.5MM X 2CM
• 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: 10932563
• Report Number: 3008881809-2020-00373
• Device Sequence Number: 19364883
• Product Code: HCG
• UDI-Device Identifier: 04546540698032
• UDI-Public: 04546540698032
• 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): 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: M0035431520
• Device Catalogue Number: M0035431520
• Device Lot Number: 21811235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/08/2021
• 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: ENVOY DA 6F (CODMAN NEURO); NEUROFORM EZ 3.5*20 (STRYKER); SL-10 MICROCATHETER (STRYKER); SYNCHRO 2 (STRYKER); TARGET 360 1.5*2 (STRYKER); TARGET 360 2*3 (STRYKER); TARGET HELICAL 1.5*2 (STRYKER); XT-27 MICROCATHETER (STRYKER)
• Patient Age: 58 YR