MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number UNKNOWN

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thromboembolism (2654)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device a supplemental report will be filed.Related mdrs for this event: 2029214-2019-00569, 2029214-2019-00570, 2029214-2019-00571.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that increased friction lead to more manipulations, which, in turn, lead to 2 thromboembolic events of the middle cerebral artery (mca) branches.The patient was undergoing double catheter technique coiling treatment for a small aneurysm on the m1-m2 junction of the right middle cerebral artery (mca).The vessel was observed moderately tortuous.Prior the event, it was reported that the physician decided to use double catheter technique.He used one echelon 10 and one echelon 10 45-degree microcatheters and were placed both in the aneurysm.The microcatheters were prepared in accordance to the ifu and were under continuous saline drip.The physician delivered coils through one microcatheter without problems.During the placement of the first coil in the second microcatheter, the physician noticed increased friction in one of the microcatheters.He decided to continue with the delivery of the coil, despite the increased friction, and he delivered and detached the coil.The second coil he decided to use through this microcatheter was the apb-2-3-hx-ss.Again, he noticed increased friction which lead to ¿snaking¿ of the coil inside the microcatheter.He retrieved the microcatheter and it was placed aside for return and further evaluation.The aneurysm was treated with coils delivered from the first microcatheter.It is the physician¿s view that the increased friction lead to more manipulations, which, in turn, lead to 2 thromboembolic events of the mca branches.The physician did super selective catheterization of mca branches and administered iib iiia inhibitor to resolve the thrombi.The superior and front opercular branches of the mca remained occluded but the patient had good collaterals and slight neurological symptoms were noticed because of this event.According to the physician she is doing well but she has some slight neurological problems (headaches and minor memory disorders).

• Brand Name: AXIUM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8704438
• MDR Text Key: 148185855
• Report Number: 2029214-2019-00572
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K151447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 50 YR
• Patient Weight: 70