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

Model Number 105-5081-153

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

Patient Problems Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Menstrual Irregularities (1959); Pain (1994); Anxiety (2328); Pseudoaneurysm (2605); Syncope/Fainting (4411)

Event Date 11/17/2021

Event Type  Injury  

Event Description

Senechal q, echegut p, bravetti m, et al.Endovascular treatment of pelvic congestion syndrome: visual analog scale follow-up.Frontiers in cardiovascular medicine.2021;8:751178.Doi:10.3389/fcvm.2021.751178.Medtronic literature review found a report of patient complications in association with onyx.The purpose of this article was to evaluate medium-term clinical outcomes of transcatheter embolization and stenting in women with several pelvic venous disorders responsible for chronic pelvic pain and varicose veins of the lower limbs.The study population included 327 consecutively recruited patients referred to the interventional radiology unit from january 2014 to december 2019 due to chronic pelvic congestion, lower limb varices, or a combination of both the symptoms.The mean age was 41.9 years.Overall, 614 embolization procedures were performed in 327 patients on overall 1 ,468 veins.A total of 69 angioplasties with stent placement (22 for ncs and 47 for mts) were carried out.In all the cases, diagnostic venography was conducted by using a transfemoral or brachial approach under local anesthesia in semi-upright position.The brachial approach was used when the right ovarian vein had to be embolized.A 5-fr introducer sheath (radiofocus, terumo europe, leuven, belgium, uk) was placed in the femoral vein (or brachial vein) and a 4-fr cobra ii customized guiding catheter (terumo europe, leuven, belgium, uk) was advanced up in order to investigate the gonadal veins and afferent vessels.For brachial access, a 4- fr vertebral (terumo europe, leuven, belgium, uk) guiding catheter was used.Embolization was indicated for all the ovarian and pelvic veins demonstrating reflux, whether spontaneously or following a valsalva maneuver.A microcatheter (rebar, medtronic, or progreat, terumo, tokyo, japan) was employed to selectively catheterize the most distal pathological vein.Onyx is an elastic ethylene vinyl alcohol copolymer that is dissolved in dimethyl sulfoxide (dmso) with micronized tantalum powder, thereby providing contrast for fluoroscopic visualization.All the embolization procedures were conducted under controlled with an anesthesiologist with general sedation at the time of dmso injection.The aim of embolization was to fill as many pelvic varicose veins as possible with onyx and to close venous communications and reflux veins.Onyx 34l was slowly injected under fluoroscopic control on road mapping, so as to ensure full control and visualization to diminish the risk of non-target embolization.No coils or occlusion balloon was employed, when onyx reflux arises near an anastomosis of the internal iliac vein or not target veins since the injection was stopping few seconds.The microcatheter was then pulled back and the injection resumed.After embolization of pelvic varicose veins, the insufficient vein was embolized with regular removal of the catheter.No coils were used to complete the embolization.Following the embolization procedure, another pelvic venogram was carried out in order to visualize complete or incomplete occlusion of pathological veins.The article states the following technical issues during use of the onyx.-asymptomatic onyx migration the following intra- or post-procedural outcomes were noted: -14 patients required repeated treatment in an already embolized vein because of symptom recurrence.-a technical embolization failure occurred in one patient -four major complications as follows: an allergic bronchospasm requiring 72-h hospitalization, a false common femoral artery aneurysm treated by direct embolization, one asymptomatic onyx migration, and one infectious syndrome at day 15 postembolization.-there were 16 minor complications recorded as follows: a panic attack, seven delayed allergies, a severe vagal reaction requiring 1-day hospitalization, four phlebitis at perfusion site cases, and four dyspnea cases at home, yet without any abnormality detected upon checkup in the emergency room.-one patient suffering from salpingitis was operated at 1-month postintervention.-pelvic pain was still present in 114 patients, but its mean vas-recorded intensity had decreased from 7.0 before treatment to 1.2 at 1 year.Dysmenorrhea, dyspareunia, and postcoital pain that had been present in 260, 164, 226 patients prior to embolization were only still present in 58, 57, and 34 patients at 1 year with markedly decreased intensity levels -partial clinical success was recorded in 101 cases.-no clinical change was observed in 29 cases.Worsening was noted in three patients (one patient reported a deterioration in her qol due to vulvar pain during sexual intercourse and sports and two others suffering from enhanced inguinal pain) -seven patients declared no amelioration.-14 patients experienced a recurrence of symptoms after clinical improvement.-259 patients had no change in menstrual periods, 8 patients experienced irregular cycles, and 21 patients had an improvement in menstrual cycle regularity after treatment.

Manufacturer Narrative

Continuation of d10: product id: unk-nv-onyx; product id: unk-nv-onyx; g2: citation: authors: senechal, q., echegut, p., bravetti, m., florin, m., jarboui, l., bouaboua, m., teriitehau, c., feignoux, j., legou, f., pessis, e.Endovascular treatment of pelvic congestion syndrome: visual analog scale follow-up.Frontiers in cardiovascular medicine 8:751178 2021.Doi:10.3389/fcvm.2021.751178.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.

• 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: 17417484
• MDR Text Key: 320117560
• Report Number: 2029214-2023-01225
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093750
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female