MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the patient had ischemic stroke post-procedure at the right mca(middle cerebral artery) bifurcation inferior division territory.Per progress note, small right-temporal infarction is likely attribute table to rapid thrombosis of the aneurysm and subsequent embolization, precipitated by profound postoperative hypertension.Heparin 8000 unit iv once was administered to the patient.The patient was treated with interventional radiology stroke therapy and injection of heparin 4000 units and 4mg ia tpa under fluoroscopy.The event of stroke is still ongoing.No other information was provided.
Additional Manufacturer Narrative
B5 executive summary: updated - based on additional information received on (b)(6) 2022 that the stroke post procedure was caused by embolic occlusion of right mca branch.B6 relevant tests and lab data : updated.F10 / h6 health effect - clinical code - updated.
Event or Problem Description
It was reported that the patient had ischemic stroke post-procedure at the right mca(middle cerebral artery) bifurcation inferior division territory.Per progress note, small right-temporal infarction is likely attribute table to rapid thrombosis of the aneurysm and subsequent embolization, precipitated by profound postoperative hypertension.Heparin 8000 unit iv once was administered to the patient.The patient was treated with interventional radiology stroke therapy and injection of heparin 4000 units and 4mg ia tpa under fluoroscopy.The event of stroke is still ongoing.No other information was provided.Based on additional information received on 29-december-2022 that the patient stroke post procedure was caused by embolic occlusion of right mca branch.There were no any difficulties encountered during the procedure that could have contributed to the patient¿s stroke post procedure as the subject coil performed as intended.
Additional Manufacturer Narrative
Section d catalog # search/gim search results/ product long description/ gim search results: corrected, section d lot #: corrected, h4 manufacturing date ¿ added, d4 expiration date ¿ added.Due to the automated manufacturing execution system (mes) system 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 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.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.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 this complaint.
Event or Problem Description
It was reported that the patient had ischemic stroke post-procedure at the right mca(middle cerebral artery) bifurcation inferior division territory.Per progress note, small right-temporal infarction is likely attribute table to rapid thrombosis of the aneurysm and subsequent embolization, precipitated by profound postoperative hypertension.Heparin 8000 unit iv once was administered to the patient.The patient was treated with interventional radiology stroke therapy and injection of heparin 4000 units and 4mg ia tpa under fluoroscopy.The event of stroke is still ongoing.No other information was provided.Update info: based on additional information received on 29-december-2022 that the patient stroke post procedure was caused by embolic occlusion of right mca branch.There were no any difficulties encountered during the procedure that could have contributed to the patient¿s stroke post procedure as the subject coil performed as intended.

• Brand Name: TARGET XL 360 SOFT 5MM X 10CM
• 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: 16040274
• Report Number: 3008881809-2022-00649
• Device Sequence Number: 20057856
• Product Code: HCG
• UDI-Device Identifier: 07613327128314
• UDI-Public: 07613327128314
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 02/27/2023

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 Expiration Date: 06/25/2025
• Device Model Number: M0036125100
• Device Catalogue Number: M0036125100
• Device Lot Number: 23727846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 12/29/2022; 02/23/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/06/2023; 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White