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 Syncope/Fainting (4411)

Event Date 12/10/2022

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 de4432-480 (b)(6).It was reported that on (b)(6) 2023, a 32mm rigid saddle ring was successfully implanted.On (b)(6) 2023, post procedure, but prior to discharge from hospital, the patient developed presyncope after ambulation, was re-admitted to intensive care unit and given intravenously fluid and was later discharged form icu in stable condition.

Manufacturer Narrative

An event of presyncope 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 all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

(b)(6) - arb pmcf (b)(6).It was reported that on (b)(6) 2023, a 32mm rigid saddle ring was successfully implanted.On (b)(6) 2023, post procedure, but prior to discharge from hospital, the patient developed presyncope after ambulation, was re-admitted to intensive care unit and given intravenously fluid and was later discharged form icu in stable condition.

Manufacturer Narrative

Correction: d4.An event of presyncope 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 all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

(b)(6).It was reported that on (b)(6) 2023, a 32mm rigid saddle ring was successfully implanted.On 10 december 2023, post procedure, but prior to discharge from hospital, the patient developed presyncope after ambulation, was re-admitted to intensive care unit and given intravenously fluid and was later discharged form icu in stable condition.

• 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: 16658888
• MDR Text Key: 312462491
• Report Number: 2135147-2023-01441
• Device Sequence Number: 1
• Product Code: KRH
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

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-32
• Device Lot Number: 8476886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 05/24/2023; Not provided
• Supplement Dates FDA Received: 06/02/2023; 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2022
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White