MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLM910040

Device Problems Device Difficult to Setup or Prepare (1487); Product Quality Problem (1506); Difficult to Advance (2920); Migration (4003); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2022

Event Type  malfunction  

Event Description

As reported by the field, during a coil embolization to the left internal carotid artery (ica), c5 segment, a lvis stent was partially released and a galaxy g3 mini 1mm x 4cm coil (glm910040, 30757502) was pushed into an echelon microcatheter (mc).The physician felt some resistance and added more force to deliver the coil to pass through microcatheter tip, the coil suddenly arrived at aneurysm without intention.The physician tried to retracted the coil, but failed, then continued to fill the aneurysm with coil.The coil was successfully released after 3 attempts and the reason was unknown.The proximal part of coil was not completely detached in aneurysm and the physician fixed it between the stent and the vessel wall with the lvis stent.The loop size of coil in aneurysm was 0.96x1.57mm which is greater in loop than ideal loop size of 1mm.Per respond of doctor, the coil was not able to be rotated randomly after repeated adjustment during the procedure, and the video showed that the coil came out in the same direction all the time.Finally, the shape of coil was not ideal.There was no patient injury reported.Additional information received indicated that no other devices were used with the same mc prior to the encountered resistance.The galaxy g3 mini was the first device which was put into the microcatheter.The coil did not appear damaged at any time.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.There was also resistance encountered when trying to retract the coil.A pre-deployment electrical testing was not performed.No additional manipulation was needed to detach the coil.There was no blood flow restriction/reduction as a result of the coil protruding.The device was not manipulated in any way prior to noticing it was out of shape.It was noted that the physician wanted to choose 1.5mm x3cm galaxy g3 mini but there was no product in the dsa room, then he chose the 1mm x 4cm galaxy g3 mini.During the procedure, he found out the coil was too big for the aneurysm.The procedure was delayed by 10 minutes due to the event.The medical imaging reviewed was reviewed by the cerenovus sr.Medical affairs director and the assessment reads as follows: ¿the description lists a problem that is noticed from the first moment of coil introduction.At this time, it is always best to remove the coil and check for integrity, before proceeding with the treatment.Also, the push against resistance is not recommended with a coil that has a helical structure that, upon forward pressure, increases the friction.Finally, the placement of the coil, as described, is not clear to me with the coil ending in an aneurysm with a forced maneuver.The coil may have been damaged, which could explain the unpredictable behavior in the aneurysm.This can, however, not be checked since the coil was implanted.The provided images do not provide an answer to what happened, and the coil is clearly located in the aneurysm, which¿ neck is covered by the lvis stent¿.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30757502 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaints could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 MINI 1MM X 4CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15893710
• MDR Text Key: 307989843
• Report Number: 3008114965-2022-00797
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080251
• UDI-Public: 10886704080251
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K171862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GLM910040
• Device Catalogue Number: GLM910040
• Device Lot Number: 30757502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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
• Treatment: LVIS STENT.