MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 23AGFN-756

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2017

Event Type  Injury  

Event Description

During an aortic valve replacement, a 23 mm regent heart valve was being implanted in a heavily calcified native aortic annulus with a narrow sinotubular junction.To achieve implantation, it was necessary to remove the valve from the holder in order to lower the valve into position through the narrow aortic root.A surgical clamp was applied to the sewing cuff while maneuvering the valve on its side through the narrow aortic root.After passing the valve through the narrow aortic root and parachuting it into the annulus, the orifice of the valve cracked with many small graphite particles being dispersed.All the particles that were visible were removed from the patient.The surgeon indicated that he has used this technique many times before without difficulty, and that this was the first time he encountered cracking.The user voiced concern that as the valve had limited remaining shelf life that the integrity of the valve may have been compromised.Per user report, the amount of force applied was not excessive and similar to the force previously applied.The valve was replaced with a 22 mm ats valve.There was a 15 minute delay in procedure while the ats valve was opened.No adverse events to the patient were reported and the patient is recovering.

Manufacturer Narrative

The results of this investigation concluded the bottom rim of the orifice contained two chips.There was no evidence of material defect in the carbon coating that may have caused or contributed to the orifice damage.Rather orifice damage was caused by some external force applied to the valve which overstressed the carbon material.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by the review of the device history record and by the analysis performed.The cause of the reported event remains unknown, however, information from the field indicated a surgical clamp was applied to the sewing cuff to maneuver the valve on its side through the narrow aortic root.To minimize direct handling of the valve during implantation the holder/rotator should be used to seat the valve in the annulus.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6575375
• MDR Text Key: 75449280
• Report Number: 2648612-2017-00060
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2017
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 3881640
• Other Device ID Number: 05414734006095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 76