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

Model Number 690R30

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

Patient Problem Complete Heart Block (2627)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

Citation: werner p et al.Extra-anatomic aortic bypass with aortic-, mitral-, and tricuspid surgery in a (b)(6) year old: a single-stage approach for complex coarctation associated with triple valve pathology.J card surg.2020 apr;35(4):937-939.Doi: 10.1111/jocs.14465.Epub 2020 feb 17.Earliest date of publish 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature case report regarding a (b)(6) year old female patient with a history of hypertension and chronic obstructive pulmonary disease who presented with dyspnea related to multiple valve pathology with associated coarctation.Transesophageal echocardiography revealed a stenotic bicuspid aortic valve and insufficient mitral and tricuspid valves.A single-stage surgical repair of coarctation associated with the aortic, mitral, and tricuspid valves was performed.During the procedure, the patient¿s native mitral valve was deemed not repairable.Consequently, a non-medtronic mechanical valve was implanted in the mitral position followed by aortic valve replacement with a non-medtronic mechanical valve.Lastly, the patient¿s tricuspid valve was repaired with a 30 mm medtronic contour 3d annuloplasty ring (serial number not provided).Following the procedure, the patient had complicated respiratory weaning and spent thirty-nine days on a respirator.On an unspecified date between completion of the procedure and hospital discharge, a permanent pacemaker was implanted due to total atrioventricular block.The patient was discharged in improved general condition seventy-nine days after the procedure.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Additional information received from the physician/author updated the following data fields: a4 - patient weight updated.B5 - additional information received from the physician/author stated the tricuspid repair could be a cause of the observed total at proventricular block.However, the physician/author also reported the patient's aortic root was "very small" and that the total atrioventricular block was likely related to the aortic valve replacement and subvalvular myectomy.D4 - model #, catalog #, expiration date, serial #, and unique identifier (udi) # updated.H4 - device mfg date updated.A search of the medtronic global complaint handling database with the provided device identifier serial number confirmed these observations have not been previously reported.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: 10371013
• MDR Text Key: 209167721
• Report Number: 2025587-2020-02514
• 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
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2024
• Device Model Number: 690R30
• Device Catalogue Number: 690R30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 86