MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT STANDARD AORTIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500FA

Device Problems Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Host-Tissue Reaction (1297); Aortic Valve Stenosis (1717); Cardiac Arrest (1762); Thrombus (2101)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

Citation: park pw et al.Clinical outcomes of repeat aortic valve replacement for subaortic pannus in mechanical aortic valve.Circ j.2018 sep 25; 82 (10): 2535-2541.Doi: 10.1253/circj.Cj-18-0352.Epub 2018 jul 31.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.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the early and late clinical outcomes after repeat aortic valve replacement for subaortic pannus formation in patients with mechanical valves and to analyze the postoperative hemodynamic changes in recurrent prosthetic aortic stenosis.All data were collected from a single center between january 2001 and august 2017.The study population included 51 patients (predominantly female; mean age 59 years), 15 of which were implanted with a medtronic hall mechanical valve (11 patients with 20 mm, 4 with 22 mm), 8 were implanted with a medtronic ats mechanical valve (3 patients with 19 mm, 5 with 21 mm), and 1 was implanted with a 21 mm medtronic hancock ii bioprosthetic valve.No serial numbers were provided.Among all patients, 6 deaths occurred.Of those, the causes of death were: heart failure (3), hepatocellular carcinoma (1), sepsis (1), and unknown etiology (1).Multiple manufacturers were noted in the literature; based on the available information, medtronic product did not cause or contribute to these deaths.Among all patients, adverse events included: repeat aortic valve replacement (existing mechanical valve explanted and replaced with a new tissue or mechanical valve), emergent surgery due to aortic regurgitation, severe prosthetic aortic stenosis caused by pannus formation, cardiogenic shock, extracorporeal membrane oxygenation for cardiac arrest, thrombus, brain damage, intra-aortic balloon pump support and increased transprosthetic mean pressure gradients.Late outcomes after repeat aortic valve replacement included: reoperation, recurrent prosthetic aortic stenosis, cardiac transplantation, prosthetic valve endocarditis (required surgical intervention in 1 patient), cerebral hemorrhage, and increased transprosthetic mean pressure gradients.Multiple manufacturers were noted in the literature; however, based on the available information, medtronic product may have caused or contributed to these adverse events.Among all patients, device malfunctions included: aortic regurgitation caused by acute malfunction of medtronic hall valve and cardiogenic shock due to acute malfunction of mechanical aortic valve.Multiple manufacturers were noted in the literature; however, these malfunctions may have been attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.

• Brand Name: OPEN PIVOT STANDARD AORTIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8152415
• MDR Text Key: 129965159
• Report Number: 3008592544-2018-00057
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P990046
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500FA
• Device Catalogue Number: 500FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• 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: 59 YR