MAUDE Adverse Event Report: RAPID-MEDICAL LTD COMANECI EMBOLIZATION ASSIST DEVICE; COMANECI 17

Model Number ANPP7199

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

Patient Problem Aneurysm (1708)

Event Date 08/04/2022

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 56 year old female that was treated with comaneci 17 was characterized by the study independent data safety monitoring board (dsmb) as a device-related event.The patient was diagnosed with incidental r ica terminus aneurysm and presented for elective coil embolization on 4 august 2022.The angiographic study demonstrates a bilobed right ica terminus aneurysm that measures 6.1 x 7.1 x 6.0 mm with a 4.0 mm neck.During the embolization, the comaneci device was opened and closed as needed to assure proper coil placement.Intermittent dsa was performed demonstrating progressive occlusion of the aneurysm.After placement of the last coil, the microwire was re-inserted and the microcatheter was removed from the aneurysm without complication.When the comaneci device was deflated for the final time a coil loop protruded from the aneurysm and then became attached to the device.The physician attempted to insert a transform balloon in order to occlude the aneurysm neck while the last coil was being pulled out of the aneurysm to protect the first 2 coils from being pulled out of the aneurysm.During the removal of the comaneci device, the third coil pulled partially out the aneurysm but then became detached from the comaneci device and was loose in the ica.Then the coil migrated up into the ica terminus with the flow.In addition, there was catheter related ica vasospasm that resolved by pulling the catheter proximal to the spasm and injecting 10 mg of intra-arterial verapamil.At this point a sl 10 microcatheter was advanced into the mca and a atlas stent 4 x 24 mm was deployed from the m1 down to the supraclinoid ica to tack the coil loops up against the wall.Repeat angiography demonstrated improved flow and no evidence of thrombus formation.The majority of the coil loops were tacked against the stent in the m1 however there was 1 coil loop in the a1 that was not flow-limiting.The decision at this point was made to terminate the procedure.Final dsa in the working view demonstrated stagnant contrast within the aneurysm (modified raymond iiia).Final cranial and cervical angiography was stable compared to baseline without evidence of complications.24-hour post procedure neuro examination remains intact, glasgow coma score =15, the subject was awake and alert.A small hematoma developed at the access site.The subject was discharged on (b)(6) 2022.

• Brand Name: COMANECI EMBOLIZATION ASSIST DEVICE
• Type of Device: COMANECI 17
• Manufacturer (Section D): RAPID-MEDICAL LTD; carmel building, pob 337; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): RAPID-MEDICAL LTD; carmel building, pob 337; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: orit yaniv ; carmel building, pob 337; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 15741161
• MDR Text Key: 303149939
• Report Number: 3009957947-2022-00015
• Device Sequence Number: 1
• Product Code: PUU
• UDI-Device Identifier: 07290015107150
• UDI-Public: (01)07290015107150(17)240531(10)211224CS01
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ANPP7199
• Device Catalogue Number: ANPP7199
• Device Lot Number: 211224CS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female