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

Catalog Number CDS0601-XTR

Device Problem Incomplete Coaptation (2507)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Pleural Effusion (2010); Pulmonary Edema (2020); Tachycardia (2095); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4+ and prolapsed posterior leaflet.A steerable guide catheter (sgc) was advanced to the mitral valve, but due insufficient height of the patient¿s atrial septal puncture, excessive torque was required on the sgc shaft.Knob resistance had occurred.The procedure was completed with three mitraclips implanted.The mr was reduced to trace.On (b)(6) 2023, the patient returned with malignant heart failure, sudden severe breathing difficulties, both lungs were filled with moist rales and wheezing sounds, fast heart rate, and often audible galloping rhythm at the apex of the heart.An echocardiogram was performed and revealed that recurrent mitral regurgitation (mr) with grade 3-4, and the third implanted clip had detached from the posterior leaflet and remained attached to anterior leaflet (single leaflet device attachment/slda).No additional information was provided.

Event Description

N/a.

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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported incomplete coaptation (slda, single leaflet device attachment), associated with the clip detaching from the posterior leaflet post procedure, appears to be due to challenging anatomy with posterior prolapse and large coaptation gap, in conjunction with inadequate septal puncture height during clip positioning.The reported recurrent mr and dyspnea appears to be secondary to the slda.The cause of the reported heart failure, cardiac arrhythmia, tachycardia, and pulmonary edema could not be determined.The reported patient effects of heart failure, mitral regurgitation, dyspnea, cardiac arrhythmias (including tachycardia), and edema as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: code 2010 - pleural effusion removed.

• 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: 18243556
• MDR Text Key: 329430055
• Report Number: 2135147-2023-05283
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2024
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 30523R2032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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: IMPLANTED MITRACLIP (X2)
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Race: Asian