MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; TIMER, CLOT, AUTOMATED

Model Number 305

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Death (1802); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Transient Ischemic Attack (2109)

Event Date 09/05/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score¿matched case-control study citation: am heart j.2012 dec;164(6):910-7 (doi: 10.1016/j.Ahj.2012.09.005) authors: azeem latib, mb chb, francesco maisano, md, letizia bertoldi, md, andrea giacomini, md, joanne shannon, md, micaela cioni, md, alfonso ielasi, md, filippo figini, md, kensuke tagaki, md, annalisa franco, md, remo daniel covello, md, antonio grimaldi, md, pietro spagnolo, md, gill louise buchannan, md, mauro carlino, md, alaide chieffo, md, matteo montorfano, md, ottavio alfieri, md, and antonio colombo, md date accepted by publisher used for event date.

Event Description

Medtronic received information via literature review of a study performed to compare outcomes after transcatheter aortic valve replacement (tavr) and surgical aortic valve replacement (savr) in patients with severe symptomatic aortic stenosis.The study population included 405 patients (mean age 79.8 years), 276 of which underwent tavr from november 2007 thru february 2011 and 129 of which un derwent savr from august 2003 thru june 2008.A propensity score matching based on clinical characteristics and surgical risk scores was then utilized to compare 222 patients (111 from each the tavr and savr groups).Of the 111 tavr patients, 41 received a medtronic transcatheter bioprosthetic valve (serial numbers not reported).Of the 111 savr patients, 26 received a medtronic surgical bioprosthetic valve (serial numbers not reported).Among all 222 matched patients, 16 total cardiovascular deaths (7 tavr; 9 savr) occurred within one year follow-up.No deaths were directly attributed to medtronic products.Among all 222 matched patients, peri-procedural and in-hospital adverse events included: 150 life-threatening/major bleeding complications (68 tavr; 82 savr), 38 acute kidney injury (9 tavr; 29 savr), 16 permanent pacemaker (13 tavr; 3 savr), 16 major vascular complications (tavr only), 4 repeated intervention for unspecified valve-related malfunction (3 tavr; 1 savr), and 2 surgical interventions (savr only).Adverse events up to one year post-implant included: 15 stroke/transient ischemic attack (5 tavr; 10 savr), and 2 myocardial infarction (savr only).The authors noted a significantly higher incidence of permanent pacemaker required for medtronic transcatheter bioprosthetic valves (10/41) as compared with non-medtronic transcatheter bioprosthetic valves (3/70).Apart from this statement, no other adverse events were directly attributed to medtronic products.No additional adverse patient effects were reported.Additional information has been requested.

Manufacturer Narrative

No device was returned and no unique device identifier (serial/lot) numbers were provided.Without unique device identifier information a review of the device history record could not be performed and root cause could not be determined.

Event Description

Requests for additional information provided no further details.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: TIMER, CLOT, AUTOMATED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5128338
• MDR Text Key: 27505800
• Report Number: 2025587-2015-01039
• Device Sequence Number: 1
• Product Code: GKN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P990064
• 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: Followup,Followup
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305
• Device Catalogue Number: 305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2015
• 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 Age: 00080 YR