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

Model Number UNK-NV-ECHELON

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

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/14/2021

Event Type  Death  

Manufacturer Narrative

Ökçesiz, i., dönmez, h., vural, a., karabiyik, ö., yüce, i., & çagli, s.(2021).The role of ct angiography and endovascular treatment in acute-massive head and neck bleeding.European archives of oto-rhino-laryngology, 279(2), 875¿882.Https://doi.Org/10.10 07/s00405-021-06813-6.Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.If information is provided in the future, a supplemental report will be issued.

Event Description

Ökçesiz, i., dönmez, h., vural, a., karabiyik, ö., yüce, i., & çagli, s.(2021).The role of ct angiography and endovascular treatment in acute-massive head and neck bleeding.European archives of oto-rhino-laryngology, 279(2), 875¿882.Https://doi.Org/10.10 07/s00405-021-06813-6.Summary: to report the results of the endovascular treatment of acute-massive head and neck bleeding in a single center and underline the value of computerized tomography-angiography and endovascular treatment of this desperate patient group.Identified events: 1 patient had a contrast-induced nephropathy, which was procedure-related.The patient died after the first week following an acute-massive bleeding attack.1 patient experienced a cerebrovascular event, which was procedure-related.The patient died after the first week following an ac ute-massive bleeding attack.6 patients underwent additional endovascular sessions due to repeating hemorrhage.The patients died due to multiple organ system failure related to their primary cancers.One of the patients died from bleeding despite receiving two successful endovascular treatment sessions within 16 days by pva and leaving the interventional radiology unit without active bleeding.Two days after the second session, a massive bleeding from the tumor tissue caused a death of the patient.

• Brand Name: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 13723271
• MDR Text Key: 286987547
• Report Number: 2029214-2022-00387
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ECHELON
• Device Catalogue Number: UNK-NV-ECHELON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2022
• 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
• Patient Outcome(s): Other; Death
• Patient Age: 56 YR
• Patient Sex: Male