FDA Adverse Event Injury Summary report: N

COMANECI 17

MDR report key: 16085542 · Received January 3, 2023

Report

Report Number: 3015531723-2023-00001
Event Type: Injury
Date Received: January 3, 2023
Date of Event: August 29, 2022
Report Date: January 3, 2023
Manufacturer: RAPID MEDICAL LTD.
Product Code: PUU
UDI-DI: 07290015107150
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THROMBUS FORMATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF COIL EMBOLIZATION ASSIST DEVICES, INCLUDING COMANECI DEVICE. THE IFU IDENTIFIES THROMBUS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

Description of Event or Problem · 0

THE FOLLOWING EVENT WAS REPORTED THROUGHOUT THE SUCCESS POST MARKET SURVEILLANCE STUDY. THE PATIENT WAS TREATED FOR RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM COIL EMBOLIZATION WITH THE COMANECI 17 AS COIL EMBOLIZATION ASSIST DEVICE. WHILE PLACING THE EMBOLIZATION COIL INSIDE THE ANEURYSM, THE PHYSICIAN NOTICED A THROMBUS FORMING WITHIN THE COMANECI STENT. THE PHYSICIAN STOPPED THE COILING AND REMOVED THE COMANECI AND THE MICROCATHETERS FROM THE PATIENT'S ANATOMY. A FOLLOW UP CONTRAST RUN STILL SHOWED SOME SLOW FILLING OF THE DISTAL RIGHT M3/M4 BRANCHES. THEREFORE, A MEDICATION WAS ADMINISTRATED, AND A FOLLOW-UP CONTRAST RUN SHOWED NORMAL DISTAL PERFUSION WITHOUT EVIDENCE OF DISTAL THROMBOEMBOLISM. A NEUROLOGICAL EXAM WAS PERFORMED 19 DAYS POST PROCEDURE, THE PATIENT WAS CLINICALLY ASYMPTOMATIC AND HAD NO CLINICAL SEQUELAE, MRS SCORE WAS 0.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
653341	COMANECI 17	COMANECI 17	PUU	RAPID MEDICAL LTD.	ANPP7199	211224CS01	07290015107150

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR	Male	Required Intervention