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

Model Number	RSAR-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Atrial Fibrillation (1729); Dyspnea (1816); Fatigue (1849); Nausea (1970); Ischemic Heart Disease (2493); Pericardial Effusion (3271); Implant Pain (4561)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
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 on (b)(6) 2021, a 30mm sjm rigid saddle ring was implanted.Post procedures an electrocardiogram (ecg) was performed and lower wall ischemia was noted.A coronary angiogram procedure (cag) was performed.The lower wall ischemia is thought to be due to the procedure.On (b)(6) 2021, atrial fibrillation and fluid overload was noted due to the procedure.On (b)(6) 2021, a pacemaker was implanted and iv medications were administrated.The patient is still experiencing dyspnea, tiredness, nausea and septum pain.The patient is recovering.The patient has a history of hypertension.Additional information is pending.(crd_985 - arb pmcf, eu1671-303; r618952601, r618146801, r618146501, r617859901, r618146801).
Additional Manufacturer Narrative
An event of lower wall ischemia, atrial fibrillation, fluid overload, dyspnea, tiredness, nausea and septum pain 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.
Additional Manufacturer Narrative
Additional information: b5, h6.
Event or Problem Description
It was reported on 19 july 2021, a 30mm sjm rigid saddle ring was implanted.Post procedures an electrocardiogram (ecg) was performed and lower wall ischemia was noted.A coronary angiogram procedure (cag) was performed.The lower wall ischemia is thought to be due to the procedure.On (b)(6) 2021, atrial fibrillation and fluid overload was noted due to the procedure.On (b)(6) 2021, a pacemaker box was implanted and iv medications were administrated.The patient is still experiencing dyspnea, tiredness, nausea and septum pain.The patient is recovering.The patient has a history of hypertension.Additional information recieved on 08/06/21; on (b)(6) 2021, decreased hemoglobin (hb) was noted and patient recieved a transfusion of 2 units of packed cells and a pericardial effusion was reported requiring drainage.On (b)(6) 2021, a pacemaker was implanted.Crd_985 - arb pmcf, eu1671-303; r618952601, r618146801, r618146501, r617859901, r618146801).

• 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
• MDR Report Key: 12293051
• Report Number: 2648612-2021-00084
• Device Sequence Number: 4411927
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2021

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: 03/28/2026
• Device Model Number: RSAR-30
• Device Catalogue Number: RSAR-30
• Device Lot Number: 7907090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/06/2021; 08/30/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 08/18/2021; 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82