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

Catalog Number CDS0702-XTW

Device Problem Failure to Advance (2524)

Patient Problems Low Blood Pressure/ Hypotension (1914); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/17/2023

Event Type  Injury  

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 failure to advance (low transseptal puncture) was due to challenging patient anatomy (abnormal bifurcation).The cause of the reported heart failure/congestive heart failure, and the reported hypotension, could not be determined.The reported patient effects of heart failure and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report heart failure and intervention with medication.It was reported that a patient presented with grade 4 mitral regurgitation (mr) and challenging anatomy for a mitraclip procedure.The inferior vena cava (ivc) had an abnormal bifurcation, and because of this the guidewire went to the tricuspid valve during several attempts to reach the septum.After over an hour the fossa ovalis was punctured.Transseptal access was difficult due to the inferior vena cava.It appeared the height was sufficient, but throughout the procedure it was noted the transseptal height was low (2-3cm).This presented challenges, as the clip could not gain enough height to be implanted on the valve.Troubleshooting to gain height was performed, but after 30 minutes the procedure was discontinued.The patient became unstable with heart failure (an ejection fraction between 10-15 percent) and hypotension.Adrenaline was administered to stabilize the patient.The procedure was discontinued without a mitraclip implanted.Per the physician, the mitraclip was responsible for the heart failure and hypotension.There were no adverse patient sequelae.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• 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: 17722881
• MDR Text Key: 323111039
• Report Number: 2135147-2023-03925
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 09/11/2023

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: 03/19/2024
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30320R1119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other