MAUDE Adverse Event Report: ABBOTT MEDICAL SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number SARP-28

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

Patient Problem Pleural Effusion (2010)

Event Date 11/23/2021

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: (b)(6), (b)(4).It was reported that on (b)(6) 2021, a 28mm seguin semi-rigid saddle ring was successfully implanted in a patient.On (b)(6) 2021, the patient was re-admitted to the hospital due to a chest x-ray discovering a right pleural effusion.The patient was intravenously administered diuretics.The patient was monitored and discharged on (b)(6) 2021.

Event Description

Subsequent to the previously filed report, additional information was received: it was reported that there had been no difficulty experienced implanting the 28mm seguin semi-rigid saddle ring.The ring had been sized using a 501 ring sizer set and the holder handle was used during procedure.The patient was in good condition at the time of report.The cause of the patient's pleural effusion is unknown.

Manufacturer Narrative

An event of pleural effusion 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.

• Brand Name: SJM SéGUIN SEMI-RIGID ANNULOPLASTY 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: 16294269
• MDR Text Key: 308753624
• Report Number: 2135147-2023-00382
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734007504
• UDI-Public: 05414734007504
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092310
• 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: SARP-28
• Device Catalogue Number: SARP-28
• Device Lot Number: 7807263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/03/2023
• 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: 01/16/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White