MAUDE Adverse Event Report: ABBOTT MEDICAL SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 27M-101

Device Problem Perivalvular Leak (1457)

Patient Problem Hemolytic Anemia (2279)

Event Type  Injury  

Event Description

The article, "mitral perivalvular leakage case complicated to hemolysis anemia", was reviewed.This article presented a case study of a (b)(6) male, who had acquired marfan syndrome and had a history of four cardio macrovascular surgeries.At the age of 33 years old the patient had ascending aorta replacement and coronary artery bypass graft surgery (cabg) due to acute type a aortic dissection.Then at the age of (b)(6) the patient had a bentall procedure with mechanical heart valve replacement (mvr) performed due to aortic regurgitation, mitral regurgitation and enlargement of aortic root.At the age of 40 the patient had a redo mvr due to prosthetic valve endocarditis (pve).At that procedure, the patient had a 27mm sjm mechanical valve implanted in the mitral position.Mitral annulus from p1 to p3 were reinforced by a bovine pericardial patch.At the age of 50 years old, the patient required prosthetic vessel replacement for a thoracoabdominal aortic aneurysm caused by chronic aortic dissection.The patient was being received a regular follow up.At the age of (b)(6), hemolysis (ldh 1272 u/l, hb 6.0g/dl) was observed.Detail examination revealed perivalvular leakage at posterior leaflet of mitral valve.It was considered that regurgitation was coming from the mitral annulus of posterior leaflet area which had been reinforced when the patient had a redo mvr with a 27mm sjm mechanical valve replacement.The patient was scheduled for a redo surgery to mitral valve.The sewing cuff of sjm mechanical heart valve was covered with neointima, so the tissue condition at the annulus which had been previously reinforced was not able to be confirmed.The hole that produced regurgitation was not able to be identified either.A hemashield patch was placed over the left atrium wall corresponding to the mitral annulus for pi and p2 to p3 area and closed.Perivalvular leakage disappeared after the surgery.Hemolysis was improved also.The patient has been stable and no recurrence has been observed as at 10 month since the surgery.No additional information was provided.

Manufacturer Narrative

As reported in a research article, a patient was implanted with a 27mm sjm mechanical valve in the mitral position.An event of hemolysis and perivalvular leak was 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.

Manufacturer Narrative

As reported in a research article, a patient was implanted with a 27mm sjm mechanical valve in the mitral position.An event of hemolysis and perivalvular leak was 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.

Event Description

The article, "mitral perivalvular leakage case complicated to hemolysis anemia", was reviewed.This article presented a case study of a (b)(6) male, who had acquired marfan syndrome and had a history of four cardio macrovascular surgeries.At the age of (b)(6)years old the patient had ascending aorta replacement and coronary artery bypass graft surgery (cabg) due to acute type a aortic dissection.Then at the age of (b)(6) the patient had a bentall procedure with mechanical heart valve replacement (mvr) performed due to aortic regurgitation, mitral regurgitation and enlargement of aortic root.At the age of (b)(6) the patient had a redo mvr due to prosthetic valve endocarditis (pve).At that procedure, the patient had a 27mm sjm mechanical valve implanted in the mitral position.Mitral annulus from p1 to p3 were reinforced by a bovine pericardial patch.At the age of (b)(6) years old, the patient required prosthetic vessel replacement for a thoracoabdominal aortic aneurysm caused by chronic aortic dissection.The patient was being received a regular follow up.At the age of (b)(6), hemolysis (ldh 1272 u/l, hb 6.0g/dl) was observed.Detail examination revealed perivalvular leakage at posterior leaflet of mitral valve.It was considered that regurgitation was coming from the mitral annulus of posterior leaflet area which had been reinforced when the patient had a redo mvr with a 27mm sjm mechanical valve replacement.The patient was scheduled for a redo surgery to mitral valve.The sewing cuff of sjm mechanical heart valve was covered with neointima, so the tissue condition at the annulus which had been previously reinforced was not able to be confirmed.The hole that produced regurgitation was not able to be identified either.A hemashield patch was placed over the left atrium wall corresponding to the mitral annulus for pi and p2 to p3 area and closed.Perivalvular leakage disappeared after the surgery.Hemolysis was improved also.The patient has been stable and no recurrence has been observed as at 10 month since the surgery.No additional information was provided.

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13563526
• MDR Text Key: 286064409
• Report Number: 3005334138-2022-00124
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27M-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR
• Patient Sex: Male