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 Problem Hemothorax (1896)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical information: crd_985 - arb pmcf, patient site id: de4432-481, r735088301.It was reported that on (b)(6) 2023, a 34mm rigid saddle ring was successfully implanted in a patient.The patient's mitral valve repair also involved a posterior leaflet cut (p2), along with chordal replacement with artificial chordae or suture.It was noted that a left atrial appendage closure and patent foramen ovale (pfo) closure were also performed during the same surgery.On (b)(6) 2023, it was noted via computed tomography scan that the patient was suffering from hemothorax.The decision was made to perform a surgical procedure to successfully removed the hematoma.There was no bleeding noted during the surgical procedure.No patient consequences were reported.

Manufacturer Narrative

An event of hemothorax was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.

Event Description

Subsequent to the previously filed report, additional information was received: it was reported that the 34mm rigid saddle ring was sized using ring sizer set.There was no difficulty implanting the 34mm rigid saddle ring.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.The patient was discharged at the time of report.The direct cause and/or origin of the patient's hematoma is unknown, but there is no allegation of malfunction against the 34mm rigid saddle ring or procedure.The ring remains implanted and has no performance issues.

• 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: 16380782
• MDR Text Key: 309597393
• Report Number: 2135147-2023-00527
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734009461
• UDI-Public: 05414734009461
• 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: 04/03/2023

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-34
• Device Lot Number: 8662807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White