MAUDE Adverse Event Report: ABBOTT MEDICAL SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number SARP-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Aneurysm (1708); Atrial Fibrillation (1729); Stroke/CVA (1770); Encephalopathy (1833); Heart Block (4444)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

(b)(4).It was reported that on (b)(6) 2023, an unknown sized rigid saddle ring was successfully implanted in a patient with leaflet restriction.Post-implant, substantial leakage was still present over the entire closing line.A smaller ring was not possible.Therefore, the surgeon elected to replace the mitral valve.On (b)(6) 2023, right sided occlusion of a distal m3 branch was suspected, however inaccessible for thrombectomy.Aneurysm was observed in the distal internal carotid right artery with a diameter of 14mm; vascular surgery was consulted.The patient experienced left arm paralysis.On (b)(6) 2023, the patient had recovery of mobility.On (b)(6) 2023, atrial fibrillation and incomplete right bundle branch block was observed, however no treatment was required.In addition, anemia with decreased hemoglobin down to 4.5mmol/l was observed and the patient was transfused 1 unit packed red blood cells.On (b)(6) 2023, fluid overload was observed and the patient's diuretic dose was increased.On 14 march 2023, delirium was observed and the patient recovered "after a few hours without treatment." no patient consequences were reported.

Event Description

(b)(6) - arb pmcf.Patient site id: (b)(6).It was reported that on (b)(6) 2023, 30mm rigid saddle ring was selected for implant.During the procedure, there was difficulties with the ring holder getting loose.The device was successfully implanted in a patient with leaflet restriction.Post-implant, substantial leakage was still present over the entire closing line.A smaller ring was not possible.Therefore, the surgeon elected to replace the mitral valve with a non-abbott device.On (b)(6) 2023, right sided occlusion of a distal m3 branch was suspected, however inaccessible for thrombectomy.Aneurysm was observed in the distal internal carotid right artery with a diameter of 14mm; vascular surgery was consulted.The patient experienced left arm paralysis.On (b)(6) 2023, the patient had recovery of mobility.On (b)(6) 2023, atrial fibrillation and incomplete right bundle branch block was observed, however no treatment was required.In addition, anemia with decreased hemoglobin down to 4.5mmol/l was observed and the patient was transfused 1 unit packed red blood cells.On (b)(6) 2023, fluid overload was observed and the patient's diuretic dose was increased.On (b)(6) 2023, delirium was observed and the patient recovered "after a few hours without treatment." no patient consequences were reported.

Manufacturer Narrative

An event of substantial leakage post implant, aneurysm, left arm paralysis, atrial fibrillation and incomplete right bundle branch block, anemia with decreased hemoglobin and fluid overload was reported.A returned device 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Arrhythmia is a potential side effect of the procedure per the rigid saddle ring instructions for use, artmt600080898 revision a.

Manufacturer Narrative

An event of substantial leakage post implant, aneurysm, left arm paralysis, atrial fibrillation and incomplete right bundle branch block, anemia with decreased hemoglobin and fluid overload was reported.It was also reported that patient was diagnosed with ischemic cerebrovascular accident or stroke within 48 hours post procedure.A returned device 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

(b)(6) - arb pmcf.Patient site id: (b)(6).It was reported that on (b)(6) 2023, 30mm rigid saddle ring was selected for implant.During the procedure, there was difficulties with the ring holder getting loose.The device was successfully implanted in a patient with leaflet restriction.Post-implant, substantial leakage was still present over the entire closing line.A smaller ring was not possible.Therefore, the surgeon elected to replace the mitral valve with a non-abbott device.On (b)(6) 2023, right sided occlusion of a distal m3 branch was suspected, however inaccessible for thrombectomy.Aneurysm was observed in the distal internal carotid right artery with a diameter of 14mm; vascular surgery was consulted.The patient experienced left arm paralysis.On (b)(6) 2023, the patient had recovery of mobility.On (b)(6) 2023, atrial fibrillation and incomplete right bundle branch block was observed, however no treatment was required.In addition, anemia with decreased hemoglobin down to 4.5mmol/l was observed and the patient was transfused 1 unit packed red blood cells.On (b)(6) 2023, neurology diagnosed the patient with ischemic cerebrovascular accident or stroke.On (b)(6) 2023, fluid overload was observed and the patient's diuretic dose was increased.On (b)(6) 2023, delirium was observed and the patient recovered "after a few hours without treatment." no patient consequences were reported.

• Brand Name: SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING
• Type of Device: 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: 16559950
• MDR Text Key: 311470533
• Report Number: 2135147-2023-01226
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734007511
• UDI-Public: (01)05414734007511(17)271116(10)8765540
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K092310
• 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,Followup,Followup
• Report Date: 04/22/2024

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: SARP-30
• Device Catalogue Number: SARP-30
• Device Lot Number: 8765540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 06/01/2023; 04/01/2024
• Supplement Dates FDA Received: 06/08/2023; 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2022
• 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; Hospitalization; Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 101 KG