MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-XTR

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

Patient Problems Angina (1710); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965); Pleural Effusion (2010); Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 05/08/2023

Event Type  Injury  

Event Description

This report is being filed due to worsening heart failure requiring treatment and mitral stenosis.Crd_956 - mitraclip china pms.Patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) with mitral annular calcification, posterior leaflet prolapse and flail.Two mitraclips were implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6)2023, the patient was admitted to the hospital with repeated chest tightness, dyspnea, and worsening heart failure was diagnosed.Per imaging, pleural effusions were noted on both sides with scattered inflammation and exudation in both lungs.Left atrial enlargement and aorta calcification, mild tricuspid regurgitation, moderate pulmonary hypertension, a trace left to right shunt was observed.Reportedly, the shunt was unrelated to any mitraclip device.The mitraclips remained fixed, without a device deficiency.The mr remained grade 1+.On (b)(6)2023, a diagnostic right ventricular catheterization was performed with post-capillary mixed pulmonary hypertension diagnosed.Per physician, the events (excluding the shunt) might be related to the mitraclip device due to the increased mitral valve pressure gradient.Mitral valve stenosis is being considered due to the clip device.Medications had been provided as treatment.On (b)(6)2023, the patient was discharged from the hospital with medication.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the reported mitral stenosis (medical therapy) appears to be due to procedural circumstances (clip implant interacting with patient pathology/ morphology).The cause of the reported angina (treatment with medication(s)) associated with the chest tightness, the reported dyspnea (treatment with medication(s)), the reported heart failure/congestive heart failure (treatment with medication(s)), the reported hypertension (treatment with medication(s)), the reported pleural effusion, the reported pulmonary edema (treatment with medication(s)) associated with the lung exudation, and the reported tricuspid valve insufficiency/ regurgitation associated with the mild tr, could not be determined.The reported patient effects of dyspnea, heart failure, mitral stenosis, hypertension, tricuspid regurgitation, effusion, angina, and pulmonary edema, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17070197
• MDR Text Key: 316766224
• Report Number: 2135147-2023-02446
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2023

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 Expiration Date: 03/04/2023
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 20303R129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 54 KG