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

Model Number 23AGN-751

Device Problem Positioning Problem (3009)

Patient Problem Death (1802)

Event Date 03/12/2018

Event Type  Death  

Event Description

On (b)(6) 2018, a 23 mm regent heart valve was implanted in the aortic valve using a sjm model 905 holder handle.The valve was not inspected before the procedure.There is no information on whether the physician tested the leaflets post implant or if the heart valve was noticed inverted if they were tested.When the valve was implanted, it was discovered to be implanted in the wrong position (inverted).The physician states that the heart valve was delivered in a factory sealed package with the valve mounted in an inverted position.The heart valve was removed, anchor knots undone, and the implant was done again.Due to the need to perform a reoperation, the associated extracorporeal circulation and aortic clamping was significantly prolonged.The patient passed away fourteen hours postoperatively due to low cardiac output.The patient did not have any comorbidities.

Manufacturer Narrative

Patient weight added.New manufacturer contact.An event of a "valve mounted in an inverted position" and patient death was reported.The results of the investigation are inconclusive since the device was not returned for analysis.However, attempts to recreate the reported issue were not successful.The design of the regent valve holder/rotator and packaging do not allow for the valve to be mounted in the opposite position.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.Per instructions for use (b)(4) ver.A, in the precautions section, "before placing sutures in the valve cuff, verify that the valve is mounted correctly on the valve holder/rotator".The directions for use section states, "use the valve holder handle to align the valve in the annulus.Orient the valve so that blood flow is always into the pivot guards".

Event Description

On (b)(6) 2018, a 23mm regent heart valve was implanted in the aortic position using a sjm model 905 holder handle.The valve was not inspected before the procedure.When the valve was implanted, it was discovered to be implanted in the wrong orientation (inverted).There is no information on whether the physician tested the leaflets post implant or if the heart valve was noticed inverted until post implant.The physician states that the heart valve was delivered in a factory sealed package with the valve mounted in an inverted position.The patient was returned to bypass, the implanted heart valve was removed, anchor knots undone, and the valve was implanted in the correct orientation.Due to the need to perform a reoperation, the associated extracorporeal circulation and aortic clamping was significantly prolonged.The patient passed away fourteen hours postoperatively due to low cardiac output.The patient did not have any comorbidities.

• Brand Name: SJM REGENT HEART VALVE
• 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7436647
• MDR Text Key: 105687176
• Report Number: 2648612-2018-00026
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: BL
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2019
• Device Model Number: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Device Lot Number: 4860839
• Other Device ID Number: 05414734006101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2014
• 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; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 76