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

Model Number UNK-NV-REBAR

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

Patient Problem Unspecified Vascular Problem (4441)

Event Date 02/01/2010

Event Type  Injury  

Manufacturer Narrative

Eberhardt km, sadeghi-azandaryani m, worlicek s, koeppel t, reiser m, treitl m.Treatment of type i endoleaks using transcatheter embolization with onyx.Journal of endovascular therapy.2014;21:162-171.Www.Jevt.Org.  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

Eberhardt km, sadeghi-azandaryani m, worlicek s, koeppel t, reiser m, treitl m.Treatment of type i endoleaks using transcatheter embolization with onyx.Journal of endovascular therapy.2014;21:162-171.Www.Jevt.Org.  the purpose of this study was to report a single-center experience with transcatheter embolization of type i endoleak s using the liquid embolic agent onyx, an ethylene vinyl alcohol copolymer.Eight patients (4 men; mean age 74.8 years, range 63¿86) with 10 type i endoleaks (6 abdominal and 4 thoracic) diagnosed 2 days to 9 years after endovascular repair were treated with onyx embolization because cuffextension was precluded by an insufficient landing zone in 6 cases and an unsuitable aortic diameter in 2.Endoleaks were accessed with a 4-f diagnostic catheter and a coaxially introduced dimethylsulfoxide-compatible microcatheter.Onyx-34 was predominantly applied due to its high viscosity; patent side branches were coil embolized prior to onyx delivery in 3 cases.  technical success of the procedure was achieved in all cases.The mean volume of onyx used for abdominal endoleaks was 11.8 ml (range 3.0¿25.5) and 19.4 ml (range 4.5¿ 31.5) for thoracic endoleaks.The average duration of the procedure was 76.7 minutes (range 34.5¿110.6), and the average radiation dose area product was 18.8 cgy*cm2 (range 10.6¿55.8).Reperfusion of the endoleak was detected in one case 2 days after the procedure.A second case showed an occluded endoleak but a small trace of contrast between the aortic wall and the stent-graft.Non-target embolization was not found in any case.Mean follow-up was 13.2 months (range 8¿24).The mean reduction in diameters for thoracic aneurysms after 6 and 12 months was 0.4 and 0.9 cm, respectively, and 0.6 and 1.2 cm, respectively, for abdominal aneurysms.  although the final angiogram always indicated complete endoleak occlusion, one severe reperfusion was found 2 days after embolization of a late abdominal type ia endoleak (patient #2).A second embolization failed, so the patient had endoanchors implanted.In a thoracic type ia endoleak (patient #6), a follow-up ct scan demonstrated occlusion of the endoleak, but revealed a small stripe of contrast flow between the aortic wall and the stent-graft heading toward the endoleak cavity.This patient is monitored every 6 months for early detection of endoleak reperfusion or sac growth, which has not been detected so far.The procedure was clinically successful in all other cases, and the endoleaks remained completely occluded with a mean follow-up of 13.2 months transcatheter embolization of type i endoleaks using onyx is a simple, safe, and sustainable treatment option with a high primary success rate for cases in which stentgraft extension is not possible.The benefit of additional coil embolization remains uncertain.   the article does not state any technical issues during use of the rebar, concerto, onyx, or echelon.   the following intra- or post-procedural outcomes were noted:  1.Endoleak.

• Brand Name: REBAR
• 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: 15353315
• MDR Text Key: 299275110
• Report Number: 2029214-2022-01496
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-REBAR
• Device Catalogue Number: UNK-NV-REBAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male