MAUDE Adverse Event Report: ABBOTT MEDICAL SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number RIGID SADDLE RING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Non specific EKG/ECG Changes (1817); Cardiac Tamponade (2226); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Crd_985 - arb pmcf.Eu1671 - 867 (r750645101, r750645901, r751356001, r751356701, r752256601, r752255701, r753442701) it was reported that on (b)(6) 2023, a 28mm rigid saddle ring was implanted in a patient.Post procedure, it was reported that the patient had systemic inflammatory response syndrome (sirs) and was treated with noradrenalin.(b)(6) 2023, the patient had electrocardiogram (ecg) changes post procedure; q waves, probably not grafted right coronary artery.The patient had accelerated junctional rhythm requiring external pacemaker setting to ventricle paced, ventricle sensed (vvi).Ecg was repeated after 1 hour, there was no evidence of transmural ischemia.On (b)(6) 2023, the patient was suffering from respiratory insufficiency, dyspnea.Requiring hospitalization to the intensive care unit probably pneumonia relating to decreased left ventricular function and right ventricular function.The patient was treated with inotropes.It was also reported that on (b)(6) 2023, the patient had decompensation cordis requiring diuretics.On (b)(6) 2023, the patient was found to have anemia.On (b)(6) 2023, the patient was treated with levosimendan.On (b)(6) 2023, the patient required an urgent pericardiocentesis due to cardiac tamponade that resulted in cardiogenic shock.The cardiac tamponade was prominent around the right atrium and right ventricle with a 40mm pericardial effusion noted.It was also noted that the patient's vena cava had widened and collapse by more than 50%.There was significant inflow variation through the tricuspid valve.It was noted that the successfully pericardiocentesis/drainage removed 750 ml of serosanguineous fluid.On (b)(6) 2023, suffered from shock due to cardiac tamponade and undrained clots that were in the patient's right ventricle.The decision was made to perform a re-sternotomy and administered the patient milrinone.On (b)(6) 2023, the patient noted as still being anemic with a hemoglobin level of 4.9 mmol/l and required a transfusion of packed red blood cells.

Manufacturer Narrative

An event of respiratory insufficiency, dyspnea, anemia, cardiac tamponade and pericardial effusion was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Patient comorbidities includes percutaneous transluminal coronary angioplasty, atrial fibrillation, ischemic cardiomyopathy, myocardial infarction, copd, hypertension, hypercholesterolemia which may have contributed to the reported event.Field indicated that the cause of the patient's pneumonia was due to the patient's decompensated state and prolonged intubation prior to procedure.Field also noted that the cause of the patient's cardiac tamponade/pericardial effusion was related to the implant procedure.The direct cause of the patient's hyponatremia is unknown, but possibly due to inappropriate antidiuretic hormone secretion syndrome.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no allegation of malfunction against abbott device.

Event Description

(b)(6) - arb pmcf.(b)(6).Subsequent to the previously filed report, additional information was received that there had been no difficulty implanting the 28mm rigid saddle ring.The patient remained hemodynamically stable throughout the procedure, but did require support after being removed from the extracorporeal circuit (ecc).There was no clinically significant delay in procedure reported.It was noted that the patient's post-implant anti-thrombotic regimen was 5000 international of units of dalteparin per day.After the successful pericardiocentesis the patient anti-thrombotic regimen was adjusted to 10,000 international units of dalteparin per day and acenocoumarol.On (b)(6) 2023, it was noted that the patient began to suffer from hyponatremia, but no treatment was performed.The cause of the patient's cardiac tamponade/pericardial effusion is attributed to the implant procedure.The cause of the patient's pneumonia is attributed to the patient's decompensated state and prolonged intubation prior to procedure.The direct cause of the patient's hyponatremia is unknown, but possibly due to inappropriate antidiuretic hormone (adh) secretion syndrome.There is no allegation of malfunction against the 28mm rigid saddle ring or procedure.The patient was stable and recovering at the time of report.

• Brand Name: SJM RIGID SADDLE RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16920106
• MDR Text Key: 315106337
• Report Number: 2135147-2023-02083
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K042734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

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: RIGID SADDLE RING
• Device Catalogue Number: RSAR-28
• Device Lot Number: 8224128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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: 65 YR
• Patient Weight: 105 KG