MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500DM27

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 09/07/2014

Event Type  Death  

Event Description

Medtronic received information that the patient with this med hall 25mm mechanical mitral valve (serial number not available) implanted twenty-five years, presented with acute mitral stenosis.An emergent explant was performed.During the explant, the annulus and tissue were found to be very fibrotic.The fibrotic tissue was excised.An open pivot mechanical valve was implanted per the usual procedure, including testing of leaflets.After going off-pump, echocardiogram showed that one leaflet did not open properly.The patient was put back on-pump, and the valve was rotated (90°).The valve leaflets were successfully tested.After going off-pump the echocardiogram again showed a leaflet did not open properly.The physician felt the leaflets were hindered by the patient¿s anatomy.According to the physician, the newly implanted valve did not have any contact with the fibrotic tissue.It was reported that the patient decompensated during the procedure and died.The physician stated the cause of death was peripheral circulatory collapse and myocardial pump failure.The med hal valve will not be returned.

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the product be returned, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, analysis found: 1.After the carbon subassembly was cleaned and dried the leaflets were fully mobile.2.During sewing cuff examination, the sewing cuff met specification for stitching and back-stitching.3.A chipout was found on the rim of the orifice along with several scratches.It appeared to have been caused by a metalic object grasping the valve.Most likely it occurred during explant.4.The dimensions for the orifice met specification.5.The dimensions for the left leaflet met specification.6.The dimensions for the right leaflet met specification.7.The crown to notch (c-n) gap was measured, the gap for the left and right leaflets were within specification.8.A continuous scan was used to assess the roundness of the stiffening ring.The dimensions met specification.

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.A review of the echocardiographic images for this case was conducted.After initial intervention, there was evidence of limited mobility or immobility of the disc in the posteromedial position.The apparent low-flow state could have contributed to limited prosthesis leaflet mobility and subsequent immobility.Analysis of the returned device showed no anomalies.From the available information and analysis of the returned device, the cause of the event was not device-related.It was reported that motion of the leaflets was successfully tested during implantation of the valve.After going off-pump, echocardiogram showed that one leaflet did not open properly.The treating physician concluded that the leaflets were hindered by the patient¿s anatomy, which is further supported by the echo images that indicate that the apparent low blood flow state may have contributed to the limited prosthesis leaflet mobility and subsequent immobility.

Manufacturer Narrative

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

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 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: 4145248
• MDR Text Key: 4933207
• Report Number: 2025587-2014-00736
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2018
• Device Model Number: 500DM27
• Device Catalogue Number: 500DM27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2013
• 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): Death