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

Model Number UNKNOWN

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

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 04/23/2020

Event Type  Death  

Manufacturer Narrative

Citation: silverberg d, bar-dayan a, rimon u, raskin d, fefer p, halak m.The jailed coiling technique for the treatment of penetrating ulcers and saccular aneurysms of the aortic arch.Vascular and endovascular surgery.2020;54(5):423-429.Doi:10.1177/1538574420921282.The concerto coil will not be returned as implanted in the patient.Base on the reported information there were not any device issue during the use.The events occurred in post procedure and cause was unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through literature review.There was 1 perioperative mortality.This patient, who had severe cardiac disease, presented with a symptomatic, enlarging 7-cm sa.The patient underwent an axillary¿axillary bypass followed by tevar and coiling of his sa.The surgery was uneventful, however he expired on postoperative day 2 due to an extensive myocardial infarction.Technical success was achieved in all patients, resulting in obliteration of the aneurysm lumen.No patient suffered from a perioper ative cerebrovascular event, spinal cord ischemia or inadvertent coverage of a supra-aortic vessel.In all cases, the coils (concerto coils) were delivered accurately, with no events of coil migration into the aorta.9 patients underwent treatment for penetrating aortic ulcers (paus) and saccular aneurysms (sas) of the arch.Mean age was 70 years (range 60-79) and all patients were male.

• Brand Name: CONCERTO NYLON HELIX
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10350489
• MDR Text Key: 201195892
• Report Number: 2029214-2020-00757
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K090046
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/15/2020
• 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): Death
• Patient Age: 64 YR