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

Model Number 680R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems High Blood Pressure/ Hypertension (1908); Left Ventricular Dysfunction (1947); Mitral Regurgitation (1964)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

Citation: regazzoli, d.Md et al.Valve in a rigid mitral annuloplasty ring optimized by post-dilatation.Jacc: cardiovascular interventions.(2017) 10(19):e177-e179.Doi: 10.1016/j.Jcin.2017.07.043 earliest date of e-publish/publish used for event date.  no unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a (b)(6) male patient with hypertension, non¿insulin-dependent diabetes, dyslipidemia, previous smoking with chronic obstructive pulmonary disease, and paroxysmal atrial fibrillation.Approximately three years prior, the patient had been implanted with a medtronic profile 3d 28mm annuloplasty ring.Serial number was not provided.A transesophageal echocardiogram (tee) indicated severe mitral regurgitation due to residual severe leaflet tethering, severe left ventricle dysfunction and moderate-to-severe pulmonary hypertension.Subsequently, a non-medtronic valve was implanted, valve in ring.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: 7049617
• MDR Text Key: 92653595
• Report Number: 2025587-2017-02241
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/21/2017

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 Model Number: 680R
• Device Catalogue Number: 680R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/21/2017
• 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: 72 YR