MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474100
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802); Hemorrhage, Cerebral (1889)
Date of Event	07/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
During a coil procedure of a ruptured 7 mm posterior communicating artery (pcomm) aneurysm, the physician reported that when placing the third coil into the aneurysm, the coil pushed the microcatheter out of the aneurysm.When the physician was trying to pull the coil back and reposition the delivery wire, the coil snapped proximally.The physician then tried to pull back the coil with the microcatheter; however, the coil migrated across the pcomm into the internal carotid artery (ica) and occluded the middle cerebral artery-m2 segment for more than 10 minutes.A snare device was used to retrieve the coil out of the patient¿s body.Half dose of abciximab (reopro) medication was given to the patient and the aneurysm was coiled further and stent was placed in the parent vessel.The next morning post procedure, the patient re-bled from the same aneurysm and passed away.The physician indicated that the initial reason for the patient death was due to the coil breaking but the final cause of death was due to the anti-platelet (reopro) medication given to the patient to stop stroke because the coil had migrated.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In the case of this complaint it is most likely that the coil broke and migrated during the procedure due to some handling issues or procedure factors encountered during use, as reported that the surgeon tried to push the coil in aneurysm and when failed he tried to pull back the coil along with the microcatheter which led to further rupturing of the aneurysm and the coil migrated.As per the additional information provided, no damage was noted to the device prior to use and the device was prepared as per direction for use (dfu).An assignable cause of procedural factors was assigned to the as reported issues ¿nv ¿ main coil migration¿ and ¿nv ¿ coil broken fractured¿, since 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 device performance was limited.Based on the investigation results and available information an assignable cause of anticipated procedural complication will be assigned to the as reported issues ¿nv - patient hemorrhage, blood loss with sequelae¿ ¿nv ¿ patient stroke¿, and ¿nv ¿ patient death¿, since the issues are due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, device labelling and/or risk documentation files.
Event or Problem Description
During a coil procedure of a ruptured 7mm posterior communicating artery (pcomm) aneurysm, the physician reported that when placing the third coil into the aneurysm, the coil pushed the microcatheter out of the aneurysm.When the physician was trying to pull the coil back and reposition the delivery wire, the coil snapped proximally.The physician then tried to pull back the coil with the microcatheter; however, the coil migrated across the pcomm into the internal carotid artery (ica) and occluded the middle cerebral artery-m2 segment for more than 10 minutes.A snare device was used to retrieve the coil out of the patient¿s body.Half dose of abciximab (reopro) medication was given to the patient and the aneurysm was coiled further and stent was placed in the parent vessel.The next morning post procedure, the patient re-bled from the same aneurysm and passed away.The physician indicated that the initial reason for the patient death was due to the coil breaking but the final cause of death was due to the anti-platelet (reopro) medication given to the patient to stop stroke because the coil had migrated.
Additional Manufacturer Narrative
In the case of this complaint it is most likely that the coil broke and migrated during the procedure due to some handling issues or procedure factors encountered during use, as reported that the surgeon tried to push the coil in aneurysm and when failed he tried to pull back the coil along with the microcatheter which led to further rupturing of the aneurysm and the coil migrated.As per the additional information provided, no damage was noted to the device prior to use and the device was prepared as per direction for use (dfu).An assignable cause of procedural factors was assigned to the as reported issues ¿nv ¿ main coil migration¿ and ¿nv ¿ main coil broken/fractured¿, since 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 device performance was limited.Based on the investigation results and available information an assignable cause of anticipated procedural complication will be assigned to the as reported issues ¿nv - patient hemorrhage, blood loss with sequelae¿ ¿nv ¿ patient stroke¿, and ¿nv ¿ patient death¿, since the issues are due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, device labelling and/or risk documentation files.As reported code was corrected from nv ¿ coil broken/fractured¿ to nv ¿ main coil broken/fractured¿.
Event or Problem Description
During a coil procedure of a ruptured 7mm posterior communicating artery (pcomm) aneurysm, the physician reported that when placing the third coil into the aneurysm, the coil pushed the microcatheter out of the aneurysm.When the physician was trying to pull the coil back and reposition the delivery wire, the coil snapped proximally.The physician then tried to pull back the coil with the microcatheter; however, the coil migrated across the pcomm into the internal carotid artery (ica) and occluded the middle cerebral artery-m2 segment for more than 10 minutes.A snare device was used to retrieve the coil out of the patient¿s body.Half dose of abciximab (reopro) medication was given to the patient and the aneurysm was coiled further and stent was placed in the parent vessel.The next morning post procedure, the patient re-bled from the same aneurysm and passed away.The physician indicated that the initial reason for the patient death was due to the coil breaking but the final cause of death was due to the anti-platelet (reopro) medication given to the patient to stop stroke because the coil had migrated.

• Brand Name: TARGET 360 SOFT 4MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7733125
• Report Number: 3008881809-2018-00325
• Device Sequence Number: 11113958
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: 07613252192756
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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,Followup
• Report Date (Section B): 10/10/2018

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: 11/30/2020
• Device Catalogue Number: M0035474100
• Device Lot Number: 20145933
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 09/19/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/12/2018; 10/10/2018
• 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 MICROCATHETER (STRYKER); STENT (UNKNOWN)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 58 YR
• Patient Weight: 50