MAUDE Adverse Event Report: RAPID MEDICAL LTD. COMANECI; COMANECI 17

Model Number ANPP7199

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 12/25/2020

Event Type  Injury  

Event Description

Following submission of the success post market surveillance study semi-annual progress report, the company became aware that a case of a (b)(6) female that was treated with the comaneci 17 was characterized by the study independent data safety monitoring board (dsmb) as a possibly device-related event, and definitely related to the procedure or the target aneurysm.The patient presented with a history of hypertension and cerebrovascular attack (2009).On (b)(6) 2020, the patient was diagnosed with a rupture right anterior communicating artery aneurysm and sah along the course of anterior cerebral arteries.The patient's condition was severe (hunt and hess score 4), and she was transferred to a dedicated center for further treatment.The aneurysm procedure was performed on (b)(6) a coiling attempt was performed while using the comaneci 17 as a coiling assist device, however, no filling of the ipsilateral aca was noted after the recapture of the comaneci device.Therefore, an atlas stent was placed from the right a1 to a2 to bail out the closure of the right aca restoring flow to the right anterior circulation.At the end of the procedure, a small catheter-related dissection was seen in the petrous section of the ica, which nearly healed by the end of the case.No aneurysm, arteriovenous malformation, fistula, or clot in the anterior cerebral arteries was seen.Complete restoration of flow to both anterior cerebral arteries was noted at the end of the case.Post-procedure: intracranial pressures elevated overnight; ct head showed right frontal aca territory infarct continued large amount of diffuse sah, continued ventricular hemorrhage, ventricles mildly decompressed.Vasospasm secondary to sah was noted on (b)(6) and ongoing at the time of discharge.Vasospasm was not noted at the 30- day follow-up.The sah and the vasospasm were determined to be related to the target aneurysm and not the comaneci device, while the stenosis requiring stenting was determined to be possibly related.

• Brand Name: COMANECI
• Type of Device: COMANECI 17
• Manufacturer (Section D): RAPID MEDICAL LTD.; po box 337, carmel building; yokneam, israel 20692 05; IS 2069205
• MDR Report Key: 12786617
• MDR Text Key: 284119959
• Report Number: 3015531723-2021-00006
• Device Sequence Number: 1
• Product Code: PUU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2021,11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/31/2023
• Device Model Number: ANPP7199
• Device Catalogue Number: ANPP7199
• Device Lot Number: 201021CS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2021
• Distributor Facility Aware Date: 11/04/2021
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female