MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number NV-8-30-HELIX

Device Problem Use of Device Problem (1670)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis (b)(4):equipment used- video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) drawing(s) referenced: n/a as found condition- the concerto device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch; within an opened concerto outer carton; within an opened concerto inner pouch and within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.Dried blood was found within the introducer sheath and on the concerto pusher.The actuator interface was found securely attached to the coupler tube.There is no evidence of detachment attempts using an instant detacher at this location.The break indicator was found broken at two locations.This is indicative of manual detachment attempts at these locations.The proximal pusher segment was still attached to the release wire.The release wire and inner liner were both found fully retracted out of the pusher.The coin was found damaged (bent).The concerto pusher was found broken at the proximal skived location.The distal segment was not returned for analysis and its location could not be determined.The implant coil was not returned as it was reported to be implanted within the patient.Testing/analysis ¿ n/a conclusion - based on the customer report and device analysis, the customer report of "release wire issues" was confirmed.The release wire was found bent at the distal coin.It is possible the damage contributed towards a non-detachment.The cause of the damage coin could not be determined as the coin was returned fully retracted out of the pusher.The reported ¿plastic string¿ was found to be the inner liner that is normally found within the pusher.It is possible the customer retracted the exposed inner liner in addition to the release wire when attempting to detach the device.The distal pusher was found broken.It is possible the break occurred due to retracting against resistance caused by potential lack of continuous flush, tortuous anatomy, or incompatible micro catheter.Customer reported patient vessel tortuosity as moderate.It is possible insufficient continuous flush was used, as blood was found to have backflow from the micro catheter into the introducer sheath.As the unknown micro catheter was not returned for analysis, any contribution of the micro catheter towards the failure could not be determined.((b)(4)) 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.

Event Description

Medtronic received information that a concerto coil had release wire issues.Patient did a preevar embolization of the right internal iliac.A cook tornado pushable coil was deployed as first coil, followed by concerto 8x30.The concerto coil was prepared as for instructions for use (ifu), deployed through a 6fr catheter.The plastic sheath was reminded not to be implanted into patient.Concerto experienced false deployment after doctor break at the short black mark and pull the wire.The coil was seen moving.Doctor tried to pull even more.Another break and pull was done.There was no more movement so the doctor decided to take out the coil pusher and plastic sheath.When he pulled out everything, he noticed a long plastic string coming out from the 6fr catheter.He did another long pull until the plastic string snapped.He used guide wire to push and then another cook tornado coil to pack down the unidentifiable plastic string, followed by a few more cook coils.It was detached with a manual break.The physician did not try to detach with another instant detacher.2 manual detachment attempts were made with the hypotube.There was no issue with the instant detacher.The physician informed that the plastic string is not radiopaque and there is nothing much can be done to locate or see from angiography.Can only hope there is nothing floating in the patient causing non target embolization.Since concerto was sandwiched between cook coils, we can consider the concerto to be safely in the internal iliac artery.The doctor agreed.This was meant to be a sample for both doctors to promote preevar coiling using concerto coils.This experience was a bad one because both are first time users.Boston interlock was the first choice but the sales rep was absent that is why concerto got a chance to be used.The patient was undergoing preevar iia embolization.Patient blood flow was normal and vessel tortuosity was moderate.From the angio image, cannot confirm if the coil s 30cm implanted.The damaged coil deployment is returned but not cleaned from blood because the plastic sheath requires flushing instead of simply washed in the basin.No patient symptoms or complication were reported.Additional information received reported the angiography shows the darker coil as cook and concerto sandwiched in between.

• Brand Name: CONCERTO NYLON
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15801268
• MDR Text Key: 307804800
• Report Number: 2029214-2022-01936
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1