MAUDE Adverse Event Report: MEDTRONIC IRELAND ASSURANT COBALT; STENT, ILIAC

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

Patient Problems Local Reaction (2035); Hemorrhagic Stroke (4417); Heart Failure/Congestive Heart Failure (4446); Unspecified Kidney or Urinary Problem (4503)

Event Date 02/15/2022

Event Type  Injury  

Event Description

The article reports on a retrospective analysis to evaluate the outcomes of interventional treatment performed in patients on lvad support in an institution between january 1, 2016 and december 1, 2020.Retrospective data of 871 patients who were on lvad support during the investigational period.Seventy-six (8.7%) patients had an in terventional procedure; 17 patients underwent transcatheter aortic valve replacements (tavr), and 61 patients underwent stent implantation into the og to treat graft stenosis, which was not caused by graft twisting.No surgical therapy for ar or isolated og obs truction (except graft twisting) was performed in patients on permanent lvad support during the study period.One patient had two tavr procedures to treat trans-stent leak and two patients had tavr and og intervention, both at two different times.Twenty patients had recurrent og obstruction which cumulated in 83 og interventions for 61 patients.Patients were allocated in the groups according to the intervention performed.Patients who underwent both procedures were listed in both groups.Outflow graft intervention group og interventions were performed in 61 patients during the investigation period.Most (93.4%) patients were on hvad support; 6.6% were on hm3 support.The duration of lvad therapy at og interventions ranged from 4 months to 10 years.Og obstruction was diagnosed based on symptoms of hf, log file analysis with decrease in pump flow and indirect signs in echocardiography (lv dilation and increased av opening time.Additionally, in most (81.7%) patients, a ct scan was conducted.In total, 83 interventions were performed either in a cardiac catheter laboratory under local anesthesia or in a hybrid operation theatre in general anaesthesia, depending on the clinical status of the patient.Vascular access was mainly (91.7%) via femoral artery.After localizing the stenosis angiographically, angioplasty via balloon dilation was performed and bare-metal non-medtronic stent or covered stents including assurant and non-medtronic stents were placed.In the majority (57.3%) of interventions, one or two stents were implanted.One patient with implantation of nine bare-metal stents had long-distance stenosis.In one patient, a redilation of a previously implanted bare-metal stent (non-medtronic) was performed after 43 days.Vascular closure was obtained surgically or with closure devices.(on-medtronic) in 40 (48.8%), 29 (35.4%), or 6 (7.3%) patients, respectively.Twenty (32.8%) patients needed two og interventions, whereas 25% received it within 1 month after the first intervention, 50% within 6 months, and 75% within 1 year.Three (4.9%) patients required three og interventions.Most (68.7%) patients were transferred to a normal ward after the intervention; the overall hospital stay was 6 (3¿11) days.In total, complications were observed after 19 (22.9%) interventions.Bleeding occurred in nine (10.8%) patients: two patients had epistaxis which required local tamponade, one developed a hematoma at the vascular access site, which needed surgical revision, and six patients had intracerebral bleeding that led to death in five patients.In one patient, bleeding occurred after systemic lysis treatment, which was administrated after og intervention for concomitant intrapump thrombosis.Rhf occurred in five (6.0%) patients and consecutively led to the death of one patient.Nonfatal complications included aki, pneumonia, allergic reaction of the skin (presumably due to contrast agent), and postoperative delirium.In one patient, an og stent dislocated into the abdominal aorta and was expanded here no further complications occurred within three postinterventional years.Two patients were admitted in prolonged cardiogenic shock due to low cardiac output.Despite promptintervention upon arrival and immediate restoration of lvad flow, the consequences of prolonged end-organ ischemia (disseminated coagulation and coecum perforation) led to death.Three (3.6%) patients died within 3 months after discharge following an og intervention secondary to nonrelated pump thrombosis, primary graft dysfunction after heart transplantation, and unknown cause.

Manufacturer Narrative

Title: interventional procedures for left ventricular assist device-associated complications authors: pia lanmueller , jaime-juergen eulert-grehn , axel unbehaun , christoph klein, matthias hommel , markus kofler , joerg kempfert, christoph hoermandinger, friedrich kaufmann , philipp stawowy , stephan journal:, asaio journal; adult circulatory support issue:2022 nov 1;68(11):1332-1338 reference: doi: 10.1097/mat.0000000000001674 a2: average age a3: majority sex 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.

• Brand Name: ASSURANT COBALT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16378751
• MDR Text Key: 309579057
• Report Number: 9612164-2023-00670
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male