MAUDE Adverse Event Report: ABBOTT MEDICAL SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number	RIGID SADDLE RING
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumonia (2011); Pneumothorax (2012)
Date of Event	10/12/2022
Type of Reportable Event	Death
Event or Problem Description
Clinical study patient id: (b)(6).It was reported that on (b)(6) 2022, a 30mm rigid saddle ring was successfully implanted.On (b)(6) 2022, the patient developed pneumothorax, which required long term ventilation and thoracotomia was performed.The cause of the pneumothorax was reported as unknown but the physician anticipated to be a procedural complication.It was also noted that the patient had bacterial pneumonia detected postoperatively and was on antibiotics therapy.The device is working as intended.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Additional Manufacturer Narrative
An event of pneumothorax requiring long term ventilation was required.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.
Additional Manufacturer Narrative
An event of pneumothorax requiring long term ventilation, sepsis, bacterial pneumonia postoperative and patient death was reported.Information from field also indicated that the cause of the death was related to multi-organ failure/sepsis.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.H6 type of investigation code: code 4119 was removed.
Event or Problem Description
Clinical study patient id: (b)(6).It was reported that on (b)(6) 2022, a 30mm rigid saddle ring was successfully implanted.On (b)(6) 2022, the patient developed pneumothorax, which required long term ventilation and thoracotomia was performed.The cause of the pneumothorax was reported as unknown but the physician anticipated to be a procedural complication.It was also noted that the patient had bacterial pneumonia detected postoperatively and was on antibiotics therapy.The device is working as intended.The patient was reported to be in stable condition.Subsequent to the previously filed report, additional information was received that on (b)(6) 2022, the patient was transferred another hospital, on ventilation, sepsis diagnosed, treatment with kathecholamine and dialysis.It was also reported that the patient passed away.The cause of the death was multi-organ failure / sepsis.

• Brand Name: SJM RIGID SADDLE RING
• Common Device Name: 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: 15854633
• Report Number: 2135147-2022-02206
• Device Sequence Number: 20440298
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2026
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-30
• Device Lot Number: 7904519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 02/16/2023; 07/26/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 02/20/2023; 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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: Death; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG