MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035425150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	02/04/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure when the physician placed the subject coil inside the patients aneurysm, its end loops were sticking out.While the physician tried to readjust the subject coil, it detached prematurely from its delivery wire.The physician used a retriever as a snare device to retrieve the subject coil from the patients anatomy.While the physician tried to re-access the aneurysm several times, the aneurysm got perforated.The patient was treated for the perforation of aneurysm.It was reported that the patient has passed away and the cause of death is unknown.No further information is available.
Event or Problem Description
It was reported that during the procedure when the physician placed the subject coil inside the patient¿s aneurysm, its end loops were sticking out.While the physician tried to readjust the subject coil, it detached prematurely from its delivery wire.The physician used a retriever as a snare device to retrieve the subject coil from the patient¿s anatomy.While the physician tried to re-access the aneurysm several times, the aneurysm got perforated.The patient was treated for the perforation of aneurysm.It was reported that the patient has passed away and the cause of death is unknown.No further information is available.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.It was reported that during the procedure, the subject coil detached prematurely and a snare device was used to recover the detached coil.While re-accessing the aneurysm, it was perforated and the patient passed.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use, the device was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, the coil was not advanced or retracted with force, and the anatomy was not tortuous.Per the physician, the perforation of the aneurysm could not be confirmed as due to the reported device and it is unknown whether the patient death was related to the subject device.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: TARGET 360 ULTRA 5MM X 15CM
• 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: 11399420
• Report Number: 3008881809-2021-00108
• Device Sequence Number: 14642479
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: 04546540675965
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 04/30/2021

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: 10/20/2023
• Device Model Number: M0035425150
• Device Catalogue Number: M0035425150
• Device Lot Number: 22536354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/30/2021
• 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: TREVO RETRIEVER (STRYKER); UNKNOWN STENT; TREVO RETRIEVER (STRYKER); UNKNOWN STENT
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention