MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 505DA20

Device Problems Material Fragmentation (1261); Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2016

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.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 during the implant of this mechanical valve, this valve was replaced; no specific failure mechanism and no adverse patient effects attributed to the valve were indicated.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the product specimen was visually examined.Light brown discoloration on the sewing ring revealed evidence of blood contact.The valve¿s orifice appeared damaged.Both leaflets were in the closed position, appeared to be intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms and orifices appeared to be intact.A small break or chip along the outflow orifice adjacent to one hinge mechanism appeared to be associated with a sharp object such as forceps.Conclusion: a review of the device history record (dhr) was performed for this valve; there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.A conclusive cause of the reported event could not be determined as there is no failure mechanism was reported; however, the damage on the orifice appeared to be caused by impact / applied force during implant procedure.

Manufacturer Narrative

Medtronic received additional information that prior to the implant of this prosthetic valve, the valve was visually inspected and appeared normal.During the implant procedure of this 20 mm mechanical valve, this valve was forced into place in the left ventricular outflow tract (lvot) with a plastic covered clamp.This clamp accidentally pushed against the outer chamber of the valve, and a tiny piece appeared to have broken from the outer rim of the valve.The physician noted elevated gradients of 135 mmhg at the aorta, and therefore replaced this valve with a smaller 18 mm mechanical valve.No other adverse patient effects were reported.

Manufacturer Narrative

A previously submitted 3500a correction to this product event indicated the analysis was in progress, when the analysis had been concluded.Conclusion: additional information was received that the small break or chip along the outflow orifice adjacent to one of the hinge mechanism was caused by the plastic clamp during implant because of the valve was too big and excessive force was applied, which led to high gradient.Eventually the valve was replaced with a smaller 18mm mechanical valve.

Manufacturer Narrative

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.

• Brand Name: AORTIC AP
• 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: 5673923
• MDR Text Key: 45724456
• Report Number: 3008592544-2016-00034
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P060025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2020
• Device Model Number: 505DA20
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2015
• 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: 14 YR
• Patient Weight: 45