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

Model Number 500

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.If the product is received for analysis, or if additional information is received.A supplemental report will be submitted.

Event Description

Medtronic received information that during the implant of this mechanical valve in the mitral position, after the valve had been sut ured in place, one of the valve leaflets became detached when the valve was being tested.The valve was inspected prior to placement and no abnormalities were observed.The valve and the detached leaflet were both explanted and another valve was implanted.The surgery time was extended for approximately 35 minutes as a result of this incident.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the valve was received loose in the original product tray and packaging, but without a valve holder.One of the leaflets was received detached from the valve with a broken piece along the edge that connected to one hinge mechanism.Small chips or gouge marks were observed on one of the inflow hinge mechanisms.The other leaflet was still attached to the valve, and appeared intact.The valve was discolored showing evidence of blood contact.One leaflet appeared intact with no evidence of damage such as cracks or surface anomalies.The other three hinge mechanisms remained intact with no evidence of damage.The inflow and outflow orifices appeared intact with no evidence of damage.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.Conclusion: the valve was built to specification and met all inspection and acceptance criteria.Based on the analysis and the reported information, a conclusive cause of the leaflet fractures cannot be determined.There are several potential causes could cause the leaflet fracture and damage: using other instruments for valve rotation, applying excessive force while rotating the valve leaflets, or rotating the valve by the leaflet rather than by the rotator, which could break the leaflet.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.

Manufacturer Narrative

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

Manufacturer Narrative

Correction was made as the original serial number reported was incorrect.The device history record was reviewed.The valve was built to specification and met all inspection and acceptance criteria.Based on the analysis and the reported information, a conclusive cause of the leaflet fractures cannot be determined.There are several potential causes could cause the leaflet fracture / damage: using other instruments for valve rotation, applied excessive force while rotating the valve leaflets, or rotated the valve using the leaflet rather than using the rotator and the twisting of the leaflet broke the leaflet.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, 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: 5973790
• MDR Text Key: 55485095
• Report Number: 3008592544-2016-00052
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2020
• Device Model Number: 500
• Device Catalogue Number: 500DM27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided; 04/13/2017; 03/08/2018
• Supplement Dates FDA Received: 04/17/2017; 09/25/2017; 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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: 47 YR