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

Model Number 680R

Device Problems Perivalvular Leak (1457); Material Separation (1562); Incomplete Coaptation (2507)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Citation: otero d., et al.Transcatheter edge-to-edge mitral valve repair for annuloplasty ring dehiscence: the peri-ring approach.Case reports-catheter cardiovasc interv.2021 apr 1;97(5):e727-e730.Doi: 10.1002/ccd.28952.Pmid: 32438485.Epub 2020 may 21.Earliest date of publish used for date of event.Medtronic products referenced: profile 3d (pma# k073324, product code: krh).Earliest approved product used for product code and pma#.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 via literature regarding a (b)(6) year-old male patient with a history of severe mitral regurgitation, left ventricular dysfunction, coronary artery disease status-post coronary bypass grafting, peripheral vascular disease, diabetes mellitus and obesity.The patient was hospitalized with severe heart failure (hf) symptoms approximately two years after he underwent implant of a 30-mm medtronic profile 3d annuloplasty ring (unique device identifier number not provided).In the year prior to hospitalization, follow-up echocardiography revealed evidence of partial annuloplasty ring dehiscence and mild-moderate mitral regurgitation (mr).Upon hospitalization, echocardiography noted severe mr and central paravalvular leak (pvl) due to mitral leaflet mal-coaptation caused by the dehiscence.The patient was treated initially with inotropic, vasodilator and diuretic medications, he later underwent transcatheter mitral valve repair using a non-medtronic clip device.The patient¿s status improved and, upon one-month follow-up after hospital discharge, was stable with improved hf symptoms and reduced mr.No additional adverse patient effects or product performance issues were reported.

• Brand Name: PROFILE 3D
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12255362
• MDR Text Key: 264497633
• Report Number: 2025587-2021-02423
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 680R
• Device Catalogue Number: 680R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2021
• 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; Life Threatening; Required Intervention