MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR CONCERTO; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number UNK-NV-CONCERTO

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

Patient Problems Pulmonary Embolism (1498); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2013

Event Type  Injury  

Manufacturer Narrative

Raj ayyagari md , taylor powell md , lawrence staib phd , julius chapiro md , juan-carlos perez-lozada md , shivank bhatia md , toby chai md , steven schoenberger md , ralph devito md , prostatic artery embolization in non-index benign prostatic hyperplasia patients: single center outcomes for urinary retention and gross prostatic hematuria, urology (2019), doi: https://doi.Org/10.1016/j.Urology.2019.11.003 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

The purpose of this article was to present outcomes for prostatic artery embolization (pae) to treat urinary retention and gross prostatic hematuria in non-index benign prostatic hyperplasia (bph) patients.75 patients undergoing pae from december 2013 through august 2018 (average age 77.5) were retrospectively reviewed.26 patients had both problems.Retention patients (ur, n=46, catheterization=162.4±148.1 days) underwent voiding trials 1-2 months post-pae, with international prostate symptom score (ipss), quality of life (qol), and post-void residual (pvr) recorded at 3, 6, 12, 24, 36 months.Pre- and post-pae hematuria-related visits were compared for gross hematuria patients (gh, n=39), as were transfusion rates for severe hematuria patients requiring bladder irrigation (sh, n=16).90-day adverse event tabulation used clavien-dindo classification.Any non-target vessels were bypassed or protectively coil-embolized using the tornado coil by cook medical or the concerto coil.All 75 patients were analyzed together regarding adverse events.Two deaths occurred <(><<)>30 days after pae.One of these patients was an immunocompromised stage-iv cancer patient who developed fungemia during an inpatient hospital stay, which progressed to sepsis and multi-organ failure.The second patient died from a cardiopulmonary complication of unrelated warfarin toxicity, presumed to be a fatal pulmonary embolism although no autopsy was performed.Both deaths were deemed unrelated to pae.Eight grade-ii catheter-associated urinary infections requiring antibiotic treatment occurred over a total of 1577 patient-catheter days, counted from day after embolization to day of catheter removal, giving a catheter-associated urinary infection rate of 5.1 per 1000 patient-cathe ter days.There were 10 grade-i events including dysuria >1 week (n=4), self-limited contrast nephropathy (n=2), access site ecchymosis (n=2), urinary retention requiring a catheter pae provided safe, effective, and durable treatment for retention and gross hematuria in non-index bph patients.Adverse events included: 1.Dysuria 2.Contrast nephropathy 3.Access site ecchymosis 4.Sepsis 5.Urinary tract infection 6.Pulmonary embolism.

• Brand Name: CONCERTO
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16039815
• MDR Text Key: 306073859
• Report Number: 2029214-2022-02168
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-CONCERTO
• Device Catalogue Number: UNK-NV-CONCERTO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• 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): Life Threatening