FDA Adverse Event Injury Summary report: N

COMANECI EMBOLIZATION ASSIST DEVICE

MDR report key: 16774414 · Received April 20, 2023

Report

Report Number
3009957947-2023-00007
Event Type
Injury
Date Received
April 20, 2023
Report Date
April 20, 2023
Manufacturer
RAPID MEDICAL LTD
Product Code
PUU
PMA / PMN Number
DEN 170064
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

RAPID MEDICAL LITERATURE REVIEW FOUND A REPORT OF COIL ENTANGLEMENT WITH THE COMANECI EMBOLIZATION ASSIST DEVICE (SIOUTAS GS, SALEM MM, BURKHARDT J, ET AL COMANECI-ASSISTED COILING OF A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM: AN UNUSUAL CASE OF COIL RETENTION JOURNAL OF NEUROINTERVENTIONAL SURGERY PUBLISHED ONLINE FIRST: (B)(6) 2023). THE PURPOSE OF THIS ARTICLE WAS TO PRESENT A CASE OF COILING A 5MM RIGHT POSTERIOR COMMUNICATING ARTERY RUPTURED ANEURYSM USING COMANECI AS AN ASSIST DEVICE IN A 70-YEAR-OLD PATIENT WHO WAS PRESENTED WITH SUBARACHNOID HEMORRHAGE. DURING THE PROCEDURE FIRST COIL WAS PLACED PROPERLY, HOWEVER, AFTER DETACHMENT OF THE SECOND COIL, PARTIAL COLLAPSE OF THE COMANECI DEVICE SHOWED A COIL LOOP THAT WAS ADHERENT, CONSEQUENTLY, THE COMANECI WAS RETRIEVED WITH THE ADHERENT COIL WITH NO SEQUELS. SINCE THE SUBJECT ANEURYSM WAS PARTIALLY OCCLUDED, A 4X12 MM PIPELINE EMBOLIZATION DEVICE WAS PLACED ON POST BLEEDING DATY 19 WITH NO COMPLICATIONS. ACCORDING TO THE AUTHOR COIL ENTANGLEMENT WITH THE COMANECI DEVICE IS RARE BUT POSSIBLE, THEREFORE, IT SHOULD BE IMMEDIATELY IDENTIFIED DURING PROCEDURE TO PREVENT FURTHER COMPLICATIONS. IT IS RECOMMENDED TO MAINTAIN A WORKING ANGLE THAT SHOWS THE BOUNDARY BETWEEN THE COIL AND THE DEVICE AT THE NECK OF THE ANEURYSM AND TO DEFLATE THE DEVICE BEFORE DETACHING EACH COIL, AS RECOMMENDED IN THE DFU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1614215 COMANECI EMBOLIZATION ASSIST DEVICE COMANECI PUU RAPID MEDICAL LTD ANPP7177

Patients

Seq Age Sex Outcome Treatment
1 Unknown Required Intervention