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

Model Number	RSAR-32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Pulmonary Emphysema (1832); Hypoxia (1918); Pleural Effusion (2010); Pneumonia (2011); Pneumothorax (2012)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2022, a 32 mm sjm rigid saddle ring was implanted.Post procedure, the patient presented with junctional rhythm.No medical intervention was performed.On (b)(6) 2022, a small right sided pneumothorax was noted and the patient received 2 liters of oxygen.The patient did not present with any symptoms.On (b)(6) 2022, the patient was diagnosed with pneumonia and was prescribed antibiotics.On (b)(6) 2022, hypoxemia and pleural effusion was reported and required a thorax drain to be placed.The cause of the hypoxemia is caused by pleural effusion due to hematoma of the right pleural cavity.On (b)(6) 2022, the patient was transferred to the intensive care unit (icu) and a video-assisted thoracic surgery (vats) was performed.(b)(4).
Additional Manufacturer Narrative
An events of pneumonia, hypoxemia and pleural effusion caused from hematoma 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.

• Brand Name: SJM RIGID SADDLE RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, LLC; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, LLC; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13577405
• Report Number: 3007113487-2022-00047
• Device Sequence Number: 4555635
• Product Code: KRH
• UDI-Device Identifier: 05414734009454
• UDI-Public: 05414734009454
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: 09/26/2026
• Device Model Number: RSAR-32
• Device Catalogue Number: RSAR-32
• Device Lot Number: 8153637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 60 KG