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

Catalog Number CDS0705-NT

Device Problem Unintended Movement (3026)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a pericardial effusion.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 3-4, and a small atrium.An nt clip was inserted, but while applying m-knob, the clip moved in an untended direction.A pericardial effusion was then observed, causing the blood pressure and heart rate to decrease.Therefore, the mitraclip devices were removed and pericardiocentesis was performed.The blood pressure and heart rate were able to stabilized.The physician decided to continue with the procedure and one clip was successfully implanted, reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure.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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information and without the device to analyze, the cause of the reported hypotension, bradycardia, and pericardial effusion (therapy/non-surgical treatment, additional) could not be determined.The cause of the reported unintended movement (sleeve steering issues) associated with the clip moving in an unintentional direction upon applying the m knob could not be determined.The reported image resolution poor was associated with difficult imaging due to patient anatomy.The reported patient effects of hypotension, pericardial effusion, and bradycardia, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention 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

Subsequent to the initially filed report, additional information was received stating the imaging was difficult during the procedure.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16552905
• MDR Text Key: 311397012
• Report Number: 2135147-2023-01210
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/12/2023

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: 03/14/2023
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 20315R135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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: STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 16 KG