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

Model Number 680R

Device Problem Material Distortion (2977)

Patient Problems Wound Dehiscence (1154); Mitral Regurgitation (1964); Cardiogenic Shock (2262)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

Citation: hanson et al.Mitral valve repair after annuloplasty ring dehiscence using mitraclip.Catheterization and cardiovascular i nterventions 88:301¿306 (2016).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.(b)(4).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

Medtronic received information via literature regarding an (b)(6) male with non-ischemic cardiomyopathy, functional mitral and tricuspid regurgitation, heart failure, and atrial fibrillation who underwent mitral and tricuspid repair with medtronic profile 3drings (serial numbers not provided).Six months postoperative the patient presented with acute heart failure and cardiogenic shock, which required an intra-aortic balloon pump and medications.An echocardiogram revealed partial dehiscence of the mitral annuloplasty ring, distortion of the mitral valve apparatus, and severe mitral regurgitation.Subsequently, the patient underwent successful ring repair.One month later the patient had shortness of breath and moderate mitral regurgitation, which was addressed with medication.No further adverse patient effects were reported.

Manufacturer Narrative

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: 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: 6251747
• MDR Text Key: 64882071
• Report Number: 2025587-2017-00094
• 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,Followup
• Report Date: 12/16/2016

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?: Yes
• 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
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: 12/16/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 80 YR