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

Model Number 680R

Device Problems Material Separation (1562); Incomplete Coaptation (2507)

Patient Problems Endocarditis (1834); Mitral Regurgitation (1964)

Event Date 02/11/2017

Event Type  Injury  

Manufacturer Narrative

Citation: sideris k et al.Functional and degenerative mitral regurgitation: one ring fits all thorac cardiovasc surg.2019 sep 23.Doi: 10.1055/s-0039-1696989.Presented at the 46th annual meeting of the german society for thoracic and cardiovascular surgery (dgthg), leipzig, february 11¿14, 2017.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 the mid-term outcomes in patients who underwent mitral valve repair for degenerative mitral regurgitation and functional mitral regurgitation using a rigid three-dimensional ring.All data were collected from a single center between june 2009 and february 2016.The study population included 369 patients and was predominantly male with a mean age of 65 years.All were implanted with medtronic profile 3d annuloplasty rings.No serial numbers were provided.Among all patients, 9 deaths occurred during the initial hospitalization due to cardiac-related causes (5) and non-cardiac-related causes(4).An additional 25 patients died at a mean time of 2.3 years post-implant due to cardiac-related causes (1), non-cardiac-related causes (5), and unknown causes (19).No other details were reported.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: reoperation/mitral valve re-repair due to ring dehiscence, endocarditis, or systolic anterior motion.Other adverse events observed: mild-moderate-severe mitral regurgitation.Based on the available information, medtronic product was directly associated with the adverse events.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9410565
• MDR Text Key: 169243686
• Report Number: 2025587-2019-03663
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 680R
• Device Catalogue Number: 680R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• 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: 65 YR