MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

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

Echelon catheters used in the event: model: 105-5091-150, lot: a739223, mfg date: 2018-11-12, exp date: 2020-11-11.Model: 145-5091-150, lot: a761704, mfg date: 2019-01-04, exp date: 2021-01-03.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: 2029214-2019-00570, 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).

Manufacturer Narrative

D10.Device available, return date - additional information.G4.Date manufacturer received - additional information.G7.Type of report - additional information.H2.Follow-up type - additional information.H3.Device evaluation, device returned - additional information.H6.Evaluation codes - additional information, device evaluation.H10.Additional manufacturer narrative - additional information, device evaluation analysis found that the echelon-10 micro catheter was returned with the axium prime coil stuck within catheter body.The axium prime coil pushwire was found to be extending from the echelon hub and from the distal tip.The echelon-10 micro catheter was found to be compatible for use with the axium prime coil.Upon visual inspection, no issues or irregularities were found with the echelon-10 micro catheter hub or distal tip.The echelon-10 micro catheter body was found to be kinked.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed.The cause of the reported events could not be conclusively determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8704368
• MDR Text Key: 148182855
• Report Number: 2029214-2019-00569
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2019

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 70