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

Model Number CDS0701-NTW

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 02/15/2022

Event Type  Injury  

Event Description

This is being filed to report the pericardial effusion and laceration requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) and steerable guide catheter (sgc) were advanced with difficulty due to challenging imaging due to the patient anatomy.During advancement the cds came in contact with the lateral wall.The cds was continued to be steered down to the mitral valve however while steering down the patient became hemodynamically unstable and a pericardial effusion was noted.Pericardiocentesis was performed to stabilize the patient.The cds and steerable guide catheter (sgc) were removed without difficulty and the patient was transferred to surgery to address the effusion.A small laceration to the posterolateral wall of the left atrium (la) was noted and repaired surgically.No additional information was provided.

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 from the lot.Based on the information reviewed, the reported for difficult or delayed positioning appears to be related to procedural conditions.The reported poor imaging resolution appears to be due to anatomy.The reported patient effects of perforation of vessels and pericardial effusion, as listed in the mitraclip instruction for use (ifu), are known possible complications associated with mitraclip procedures.The reported perforation of vessels and pericardial effusion appeared to be due to procedural conditions.The reported hospitalization, unexpected medical intervention, and surgical intervention were a result of case specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13658973
• MDR Text Key: 286494911
• Report Number: 2024168-2022-02176
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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,Followup
• Report Date: 03/29/2022

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: 08/17/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10817R115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 107 KG