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	Pneumothorax (2012); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of emphysema and pneumothorax was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.There was no allegation of malfunction against the abbott device.The physician believed the reported event could have been an interventional complication.However, 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 regards to manufacture, design, or labeling.
Event or Problem Description
Clinical information: (b)(6).Patient site id: (b)(6) (r744186201) it was reported that on (b)(6) 2023, a 32mm rigid saddle ring was successfully implanted without any reported complication.The 32mm rigid saddle ring was sized using a ring sizer set.On (b)(6) 2023, it was noted that the patient was suffering from emphysema that progressed after extubating.A computed tomography scan and chest x-ray were performed and revealed a pneumothorax.The decision was made to slightly re-position the patient's chest tube (intercostal catheter) by pulling it, to resolved the pneumothorax.The patient was discharged at the time of report.The direct cause of the patient's pneumothorax and patient's progressive emphysema are unknown, but there is no allegation against the 32mm rigid saddle ring.

• 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): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16704903
• Report Number: 2135147-2023-01547
• Device Sequence Number: 17060552
• Product Code: KRH
• UDI-Device Identifier: 05414734009454
• UDI-Public: 05414734009454
• 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
• Report Date (Section B): 04/07/2023

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: 02/08/2026
• Device Model Number: Rigid Saddle Ring
• Device Catalogue Number: RSAR-32
• Device Lot Number: 7837582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White