MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0706-XTW

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

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Pericardial Effusion (3271)

Event Date 09/22/2023

Event Type  Injury  

Event Description

This is filed to report pericardial effusion, pericardiocentesis, hemothorax, intervention, and associated symptoms of dyspnea and low blood pressure.It was reported that a patient presented with grade 4+ mitral regurgitation (mr), frail, malnourished, mild dementia, severe pulmonary hypertension, and a baseline gradient of 3mmhg for a mitraclip procedure.There were 2 xtw clips and 1 ntw.After implanting three clips, the mr was reduced to grade <1 and the gradient was 5mmhg.All steps were followed per instructions for use (ifu) and the transseptal puncture was routine, well-visualized, and without difficulty.On saturday evening (b)(6) 2023, the patient complained of shortness of breath (sob) and had low blood pressure.An echocardiogram was performed that showed a pericardial effusion that was not hemodynamically compromising.A chest ct scan and right heart catherization displayed increased pulmonary artery (pa) and pulmonary capillary wedge pressure (pcwp) pressures.The patient became symptomatic with continued hypotension, which was treated with iv fluids.Subsequently the patient underwent pericardiocentesis.The effusion was reduced, and blood pressure and sob were improved.On monday evening (b)(6) 2023, sob occurred again.A and chest x-ray showed a left hemothorax that required a chest tube.The pericardial effusion and hemothorax did not reaccumulate after being drained.The patient was hemodynamically stable and clinically progressing.Per the physician, the pericardial effusion was highly likely to be caused by the mitraclip and the pericardiocentesis contributed to the hemothorax.No additional information was provided.

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 pe appears to be an effect of the mitraclip procedure.The reported hypotension and dyspnea appear to be a cascading effect of the reported pe.The reported pulmonary edema was the result of procedural conditions.Additionally, the reported patient effects of pericardial effusion, dyspnea, hypotension, and edema are listed in the instructions for use, and are known possible complications associated with mitraclip procedures.The reported test results, and medical interventions 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 G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17985344
• MDR Text Key: 326271230
• Report Number: 2135147-2023-04600
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2023

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: 06/03/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30605A1030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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: MITRACLIP (X2)
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 52 KG