MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION 3F AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 1000

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Myocardial Infarction (1969); Blood Loss (2597)

Event Date 10/17/2015

Event Type  Injury  

Manufacturer Narrative

Citation: r.Sorabella et al."aortic root replacement in octogenarians offers acceptable perioperative and late outcomes".Ann thorac surg 2016;101:967¿73.Http://dx.Doi.Org/10.1016/j.Athoracsur.2015.08.006 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.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 aortic root replacement in octogenarians offers acceptable perioperative and late outcomes.All data were collected from a single center between 2005 and 2012.The study population included 592 patients (predominantly male, mean age 58 years for the less than 80 group and mean age of 83 for the over 80 group), 214 of which were implanted with medtronic 3f (serial numbers not provided).Among all patients 15 deaths occurred.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients adverse events included: bleeding, stroke, new need for renal therapy, myocardial infarction, atrial fibrillation, new pacemaker placement, reoperations.Based on the available information, these adverse events may have been attributed to medtronic product.

• Brand Name: 3F AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 6853384
• MDR Text Key: 85456953
• Report Number: 2025587-2017-01562
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2017
• 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): Life Threatening; Required Intervention