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 Problems Pneumothorax (2012); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 02/22/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 312941706
• Report Number: 2135147-2023-01547
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734009454
• UDI-Public: 05414734009454
• 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: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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: Female
• Patient Weight: 83 KG
• Patient Race: White