MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number	RSAR-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Pericardial Effusion (3271); Swelling/ Edema (4577)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported on (b)(6) 2021, a 28mm sjm rigid saddle ring was implanted.There were no complications noted during the implant procedure.On (b)(6) 2021, the patient required diuretics due to edema extremities.The edema was most likely do to the procedure related to a disturbed fluid balance.The patient recieved diuretics and compression stockings to resolve the edema.The patient was reported to be recovering and was discharged on (b)(6) 2021.(b)(4).
Additional Manufacturer Narrative
Additional information: h6.An event of edema and shortness of breath were reported.A more comprehensive assessment could not be performed as the device remains implanted 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.
Event or Problem Description
It was reported on 16 august 2021, a 28mm sjm rigid saddle ring was implanted.There were no complications noted during the implant procedure.On 19 august 2021, the patient required diuretics due to edema extremities.The edema was most likely do to the procedure related to a disturbed fluid balance.The patient received diuretics and compression stockings to resolve the edema.The patient was reported to be recovering and was discharged on (b)(6) 2021.Additional information received on 09/02/21, on (b)(6) 2021, the presented unable to walk much and experiencing shortness of breath and struggling to manage self-care.A transthoracic echocardiogram (tte) was performed and shoed a pericardial fluid and a pericardiocentesis.The patient's blood pressure increased.Another tte was performed no more pericardial fluid was noted.The patient was reported to be stable.
Additional Manufacturer Narrative
Additional information: b5, h6.

• Brand Name: SJM RIGID SADDLE RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 12407619
• Report Number: 2648612-2021-00094
• Device Sequence Number: 3549192
• Product Code: KRH
• UDI-Device Identifier: 05414734009430
• UDI-Public: 05414734009430
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K042734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2024
• Device Model Number: RSAR-28
• Device Catalogue Number: RSAR-28
• Device Lot Number: 7196848
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/02/2021; 09/10/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/03/2021; 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 92