MAUDE Adverse Event Report: RAPID MEDICAL LTD COMANECI EMBOLIZATION ASSIST DEVICE

Model Number	ANPP7177
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	04/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following event was reported in the success post-market surveillance study involving a 65-year-old male with a history of hypertension and migraines.He was treated with the comaneci and atlas stent for a right posterior communicating artery aneurysm on (b)(6) 2023.On (b)(6) 2023, the patient experienced left upper extremity weakness and dysmetria, leading to hospital admission.An mri revealed multiple acute cerebrovascular accident (cva) areas, predominantly in the right bilateral watershed distribution.The patient continued dual antiplatelet therapy and statin treatment.Neurology suggested a loop recorder implant and transesophageal echocardiography (tee) for further embolic source evaluation.The patient underwent linq placement and tee, which showed no pathology to explain the cva.Cardiology recommended follow-up in one week.The patient was discharged on (b)(6) 2023, with follow-ups scheduled with his primary care physician and cardiology.The event was resolved without sequelae on june 19, 2023.
Additional Manufacturer Narrative
According to the complaint description, there's no indication of any device malfunction.Emboli formation is a known complication of wide neck aneurysm embolization treatments with assist devices.No corrective actions are required.

• Brand Name: COMANECI EMBOLIZATION ASSIST DEVICE
• Common Device Name: COMANECI
• Manufacturer (Section D): RAPID MEDICAL LTD; p.o.box 337; carmel building; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): RAPID MEDICAL LTD; p.o.box 337; carmel building; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: ina gutman ; p.o.box 337; carmel building; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 19641837
• Report Number: 3009957947-2024-00002
• Device Sequence Number: 18310991
• Product Code: PUU
• UDI-Device Identifier: 07290015107136
• UDI-Public: (01)07290015107136(17)250731(10)230212CC01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: DN170064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

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: 07/31/2025
• Device Model Number: ANPP7177
• Device Catalogue Number: ANPP7177
• Device Lot Number: 230212CC01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male