MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTOUR 3D ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number 690R

Device Problem Material Separation (1562)

Patient Problems Hematoma (1884); Right Ventricular Dysfunction (2054); Tricuspid Regurgitation (2112)

Event Date 03/07/2020

Event Type  Injury  

Manufacturer Narrative

Citation: andreas m et al.Transcatheter edge-to-edge tricuspid repair for recurrence of valvular regurgitation after left ventricular assist device and tricuspid ring implantation.Esc heart fail.2020 mar 7.Doi: 10.1002/ehf2.12577.Earliest date of publish used for event date.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through a literature case report regarding a (b)(6)-year-old female patient who presented with therapy refractory cardiac decompensation and underwent implantation of a non-medtronic left ventricular assist device (lvad) and tricuspid valve repair with a 32 mm medtronic contour 3d annuloplasty ring (serial number not provided) as a bridge to heart transplantation.On post-operative day 43, the patient was discharged for rehabilitation in good clinical condition with no signs of right heart failure.On post-operative day 53, the patient was readmitted for lvad low flow and a retrosternal hematoma compressing the right ventricle and reduced right ventricular function with severe tricuspid regurgitation were noted.On post-operative day 64, a surgical revision was performed to remove the hematoma.Right ventricular function did not improve, and inotropic therapy was initiated.Transesophageal echocardiography revealed severe central tricuspid regurgitation with poor right ventricular function.A three-dimensional transesophageal echocardiography assessment showed that the contour 3d ring appeared partially detached from the annulus with no para-annular regurgitation.Subsequently, transcatheter edge-to-edge repair was performed with two non-medtronic clip devices.Following the transcatheter repair, an echocardiogram observed a gradient through the tricuspid valve of 3 mm hg.However, right ventricular function did not recover, and the patient was kept on the waiting list for heart transplantation.The patient underwent heart transplantation thirty-one days after the transcatheter repair.Forty days later, the patient was completely asymptomatic and discharged home.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Corrected data: h6.Patient code added that was inadvertently missed during submission of the initial report.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.

Manufacturer Narrative

Additional information received from the physician/author stated that medtronic product was not related to the observed adverse events.Additional information received from the physician/author also provided the patient's weight.Updated data: a.4 - added patient weight (132 lbs) 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: CONTOUR 3D ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10075547
• MDR Text Key: 197591116
• Report Number: 2025587-2020-01667
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K101212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 690R
• Device Catalogue Number: 690R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 60