MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Intracranial Hemorrhage (1891); Ruptured Aneurysm (4436)
Date of Event	11/10/2022
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 during a stent-coiling of an unruptured acomm (anterior communicating artery) aneurysm, there was an intraprocedural rupture of the aneurysm dome.The physician had successfully placed stryker stent from the a2 to a1, and had successfully detached stryker coil inside the aneurysm dome.But, after placement and detachment of the subject coil (second coil), the physician did an angiographic run, and noticed extravasation coming from the aneurysm dome.He tried to quickly place a third coil, but the microcatheter had backed out of the aneurysm dome.So, he used a balloon as a medical intervention, and inflated it near the ica (internal carotid artery) terminus to stop the flow of blood to the acomm for about a minute.Once the balloon was deflated, he did another angiographic run, and the extravasation had stopped.After the case, the physician performed a ct scan, and commented that both the ct scan results and the patient were fine.The procedure was completed successfully.
Event or Problem Description
It was reported that during a stent-coiling of an unruptured acomm (anterior communicating artery) aneurysm, there was an intraprocedural rupture of the aneurysm dome.The physician had successfully placed stryker stent from the a2 to a1, and had successfully detached stryker coil inside the aneurysm dome.But, after placement and detachment of the subject coil (second coil), the physician did an angiographic run, and noticed extravasation coming from the aneurysm dome.He tried to quickly place a third coil, but the microcatheter had backed out of the aneurysm dome.So, he used a balloon as a medical intervention, and inflated it near the ica (internal carotid artery) terminus to stop the flow of blood to the acomm for about a minute.Once the balloon was deflated, he did another angiographic run, and the extravasation had stopped.After the case, the physician performed a ct scan, and commented that both the ct scan results and the patient were fine.The procedure was completed successfully.
Additional Manufacturer Narrative
Although the dhr (device history record) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation 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 reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that no anomalies were noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu, continuous flush was maintained throughout the procedure, the anatomy was tortuous, and the issue occurred in the anterior communicating artery (acomm).Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the reported 'patient aneurysm rupture' and 'patient intracranial hemorrhage'.

• Brand Name: TARGET 360 ULTRA 2.5MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15882821
• Report Number: 3008881809-2022-00602
• Device Sequence Number: 20114458
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: 04546540675866
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/15/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: M0035422540
• Device Catalogue Number: M0035422540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEUROFORM ATLAS STENT (STRYKER); SL-10 CATHETER (STRYKER); TARGET COIL (STRYKER); TRANSFORM BALLOON (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown