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

Model Number 23AGN-751

Device Problems Material Separation (1562); Patient-Device Incompatibility (2682)

Patient Problems Hemolysis (1886); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "bentall surgery for acute type a aortic dissection and re-repair surgery for hemolysis due to aortic root anastomotic pseudoaneurysm and artificial vessel flexion after ascending arch aortic procedure replacement" was reviewed.The research article presents a case study on a (b)(6) male who underwent emergency bentall surgery four years ago.The patient was implanted with a 23mm sjm regent artificial heart valve, 26mm triplex and the aortic arch was replaced with a 22mm triplex.The artificial blood vessel flexion was resected twice due to hemolysis.The patients hemolysis continued to reoccur and a contrast-enhanced ct was performed.A pseudoaneurysm caused by suture site detachment of the artificial heart valve and severe bent of elephant trunk at proximal to descending aorta were confirmed.The patient underwent re-operation and there were no adhesions to the pseudoaneurysm.Since the tissue on the heart side was healthy, the artificial valve was re-fixed.6 stitches were sewn to supra-annular on the base of the anterior leaflet of the mitral valve, the annulus, the artificial blood vessel, and the mechanical heart valve annulus.The non-coronary cusp(ncc) side was also fixed to reinforce 3 stitches.After that, only the stent part of open stent graft (frozenix 23 mm, stent length 150 mm) was placed in the bent part, and the procedure was completed.The operation time was over 12 hours, but postoperative hemolysis improved.Contrast-enhanced ct confirmed that there was no recurrence of pseudoaneurysm.The patient was discharged 30 days after the operation.3 month post-procedure, no hemolysis was confirmed and the patient got back to the society uneventfully.

Manufacturer Narrative

Corrected information for: h6.Additional information for: g3, g6, h2, h6, and h10.As reported in a research article, a patient was implanted with a 23mm sjm regent heart valve in the aortic position, a 26mm triplex, and had the aortic arch replaced with a 22mm triplex; an event of pseudoaneurysm, suture site detachment, reoperation, and hemolysis were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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
• MDR Report Key: 11542328
• MDR Text Key: 241494777
• Report Number: 2648612-2021-00022
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR