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

Model Number RIGID SADDLE RING

Device Problems Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/14/2022

Event Type  Injury  

Event Description

Clinical information: crd_985 - arb pmcf, patient site id: de4432-476, r727995501.It was reported that on (b)(6) 2022, a 30mm rigid saddle ring was successfully implanted in a patient.Pre-operatively the patient was found to have unspecified degenerative mitral and tricuspid valve tissue.The patient had mitral valve leaflet repair (plication), tricuspid annuloplasty, and left atrial appendage closure all during the same surgery.On (b)(6) 2022, it was discovered via a computed tomography scan, that the patient had an intrathoracic hematoma/bleeding.The decision was made to perform a surgical evacuation/drainage of the hematoma/bleeding.There was in-patient/prolonged hospitalization due to this event.The patient's condition resolved and the patient was discharged on (b)(6) 2022.

Manufacturer Narrative

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

Event Description

Clinical information: (b)(4), patient site id: (b)(6).Subsequent to the previously filed report , additional information was received that there had been no difficulty experienced implanting the 30mm rigid saddle ring.On (b)(6) 2022, it was noted via transesophageal echocardiogram that dehiscence of the 30mm rigid saddle ring had occurred due to a cardiac tear.Grade 3 mitral valve insufficiency/regurgitation was also noted via transesophageal echocardiogram and resulted in cardiac decompensation, dyspnea, and a new york heart association (nyha) functional class of 3-4.The decision was made successfully to explant the 30mm rigid saddle ring and replace it with a 33mm epic valve.The patient was stable at the time of report.The cardiac tear was due to frailty/weakness of the cardiac tissue.The mitral valve insufficiency/regurgitation was due to the ring dehiscence.There is no allegation of malfunction against the 30mm rigid saddle ring or procedure.

Manufacturer Narrative

An event of hematoma/bleeding, insufficiency/regurgitation ,cardiac tear, cardiac decompensation and explant of ring due to dehiscence was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.Information from the field indicated that it is believed that the hematoma/bleeding was caused by the disorder morbus olser, which the patient was previously diagnosed with.The cardiac tear was due to frailty/weakness of the cardiac tissue.The field also added that the regurgitation was caused by ring dehiscence.There was no allegation made against the device.Based on the information received, the cause of the reported incident could not be conclusively determined but could have been as a result of the procedure exacerbating the patient's medical condition pre-procedure.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 medical device problem code: code 2993 removed.

• 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: 16064183
• MDR Text Key: 306295518
• Report Number: 2135147-2022-02740
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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-30
• Device Lot Number: 8262078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: White