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	Abdominal Pain (1685); Ischemia Stroke (4418)
Date of Event	06/26/2021
Type of Reportable Event	Death
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 that on (b)(6) 2021, a 28mm sjm rigid saddle ring was implanted.On (b)(6) 2021, the patient was experiencing abdominal pain and a computerized tomography (ct) scan was performed.A colon ischemia was noted on the ct scan and was surgically treated.The cause of the colon ischemia is possibly due to the patient's pass history of smoking and other than that the patient did not receive any medication that can cause bowel-ischemia, neither intraoperative, nor postoperative there were no complications noted during the implant procedure.The patient suffers from persistent atrial fibrillation (af), non-ischemic cardiomyopathy (dilated), chronic obstructive pulmonary disease (copd), obesity, seronegative myasthenia gravis and polyarthritis.The patient also has a history of smoking.The patient is reported to be in stable condition and is recovering in the normal postoperative ward.Additional information received on 06/29/21 on (b)(6) 2021, the patient emerged with slurred speech and a cranial ct scan was performed and noted infract on the right hemisphere.The patient is intubated and transferred to the intensive care unit (icu).The patient does not have a history of strokes.On (b)(6) 2021, the patient was discharged form the hospital was reported to be in stable condition.(b)(4).
Additional Manufacturer Narrative
An event of abdominal pain and ischemia were reported.A more comprehensive assessment could not be performed as the device 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.
Additional Manufacturer Narrative
Corrected manufacturer narrative for h10: an event of abdominal pain, ischemia and patient death due to consequences of the stroke and comorbidities and were reported.A more comprehensive assessment could not be performed as the device 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
Subsequent to the previously filed report, additional information was received that on (b)(6) 2021, cranial computed tomography (ct) scan showed infarct on right hemisphere.Patient was diagnosed with ischemic stroke.The stroke was in the right medial steam area with edematous compression of the lateral ventricle and centerline shift.Patient was administered heparin infusion.Patient was transferred to another facility for further management.On (b)(6) 2021, patient was extubated and transferred to palliative care unit.On (b)(6) 2021, the patient died due to the consequences of the stroke and comorbidities.The cause of the stroke was unknown.There was no allegation of malfunction made against the rigid saddle ring.No additional information was provided.Clinical information: (b)(6).

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; 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: 12165603
• Report Number: 2648612-2021-00073
• Device Sequence Number: 4580703
• Product Code: KRH
• UDI-Device Identifier: 05414734009430
• UDI-Public: 05414734009430
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/21/2022

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: 09/25/2023
• Device Model Number: RSAR-28
• Device Catalogue Number: RSAR-28
• Device Lot Number: 6665256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 07/28/2021; 07/27/2022; 08/25/2022
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 07/29/2021; 08/25/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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; Death
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 102 KG