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

Model Number 500

Device Problem Material Fragmentation (1261)

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

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product has not been returned for analysis, however, the return is anticipated.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.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.

Event Description

Medtronic received information that immediately following implant of this mechanical valve, the leaflet prolapsed during leaflet rotation and and dropped inside of the heart.Subsequently, the prolapsed leaflet was extracted and the mechanical valve was explanted and replaced with a different size.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen were visually inspected.One valve with one leaflet attached and one detached leaflet were received.The valve holder and blue actuator were also returned.The attached leaflet appeared to be intact without evidence of damage such as cracks and/or surface anomalies.The detached leaflet appeared to be intact with evidence of damage such as cracks and/or surfaces anomalies.Both inflow and outflow valve hinge mechanisms appeared intact and the orifices showed no evidence of damage.Using a blue actuator to test leaflet movement, the one leaflet appeared to move without difficulty.Conclusion: 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 conclusive cause of the reported leaflet fracture could not be determined.

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, 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: 5541550
• MDR Text Key: 41661940
• Report Number: 3008592544-2016-00020
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2018
• Device Model Number: 500
• Device Catalogue Number: 500DM29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 00074 YR
• Patient Weight: 71