MAUDE Adverse Event Report: MEDTRONIC ATS MEDICAL OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500DM27

Device Problems Occlusion Within Device (1423); Incomplete Coaptation (2507)

Patient Problem Thrombosis (2100)

Event Date 01/04/2014

Event Type  Injury  

Manufacturer Narrative

Subsequently, medtronic received additional details regarding this patient¿s age ((b)(6)), gender (female), and post-implant time to the identification of the valve obstruction (approximately 41.5 months).A follow-up report will be filed when the investigation is complete or if additional information is received.

Event Description

Medtronic received information that five patients who had received replacement mechanical heart valves later underwent reoperation due to obstruction of the prosthetic valves.The information was contained in a literature article that evaluated the diagnostic use of electrocardiographically gated multi-detector row computed tomography (mdct) as a complement to echocardiography and cineradiography diagnosis for prosthetic valve dysfunction (pvd) of mechanical heart valves.It was reported that an mdct evaluation was performed on a subset of 24 patients from 270 patients who received a replacement mechanical heart valve over an eight-year period between 1997 and 2005 at a single hospital, and were followed on an annual basis with routine transesophageal echocardiogram (tee) and cineradiography on an outpatient basis.The tee and cineradiography results of the 24 patients showed normal valve function in 17 patients and prosthetic valve dysfunction (pvd) in seven.The findings of pvd included aortic prosthetic valve obstruction in four patients, an aortic annular aneurysm with paraprosthetic regurgitation in one, and a blocked leaflet in the mitral position in two.A total of 30 valves, including 23 aortic valves, 6 mitral valves, and one tricuspid valve, were subsequently evaluated via mdct.Those evaluations revealed a sub-prosthetic mass (extending from structures adjacent to the valve into the valve orifice) in all five patients with pvd (and in four patients with normal valve function in the aortic position), and one instance of an annular aneurysm.The mdct results also showed two patients with valvular masses and mitral pvd.Thrombolytic therapy for the sub-prosthetic mass was attempted in three of the five patients, but no response to the therapy was observed.Of the seven patients with atrial or mitral pvd, five underwent reoperation after the mdct evaluation (two patients declined reoperation).At reoperation, sub-prosthetic pannus in the aortic position was observed in two patients, sub-prosthetic pannus and an annular aneurysm with paraprosthetic leaks were observed in one patient, and mitral valve thrombosis was observed in two patients, confirming the findings observed on mdct.The annular aneurysm was observed in a patient who had healed infective endocarditis.The article did not report any subsequent adverse patient effects for the patients who underwent reoperation or the patients who declined.

Manufacturer Narrative

This report includes the available device and patient demographic information on the patients with mitral mechanical prosthetic valves.A separate report has been filed that includes the available device and patient demographic information on the patients with aortic mechanical prosthetic valves.Without the serial number of the products, device history records could not be pulled and reviewed.Additional information has been requested from the article¿s author contact.A supplemental report will be filed if additional information is received.Evaluation of advancing the standard valve dysfunction by multidetector-row ct teshima hideki, s.Aoyagi, t.Ueda, k.Takagi, t.Shojima, h.Tanaka j artif organs 2014 doi 10.1007/s10047-013-0751-z.(b)(4).

Manufacturer Narrative

The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The complaint information was reported from a journal article that involved seven patients with prosthetic valve dysfunction (pvd).The available information does not indicate which issues each of these devices specifically experienced.No devices have been returned for analysis.Based on the available information, a root cause could not be determined.

Manufacturer Narrative

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

• Brand Name: OPEN PIVOT AP360 HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC ATS MEDICAL; 3905 annapolis lane north; minneapolis MN 55447
• 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: 3781160
• MDR Text Key: 16283257
• Report Number: 2134151-2014-00015
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500DM27
• Device Catalogue Number: 500DM27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• 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: 00073 YR