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

Catalog Number UNK CDS

Device Problems Positioning Failure (1158); Off-Label Use (1494)

Patient Problem Atrial Flutter (1730)

Event Date 05/01/2019

Event Type  Injury  

Event Description

This is filed to report atrial flutter requiring intervention.This research article was a prospective study designed to evaluate the use of transcatheter edge-to edge repair (teer) as a safer and effective alternative to surgery in high risk patients with systemic tricuspid regurgitation (str).Complications identified in the study included positioning failure, off label use, atrial perforation, atrial flutter and unexpected medical intervention.In conclusion, percutaneous teer for str appears to be feasible, safe, and effective.Details are listed in the attached article "percutaneous edge-to-edge tricuspid repair in patients with systemic right ventricle".

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Dates estimated.The udi number is not known as the part and lot numbers were not provided.Medical device code (b)(4).The additional complications referenced will be filed under a separate medwatch report number pertaining to the steerable guide catheter.Attachment: article titled, "percutaneous edge-toedge tricuspid repair in patients with systemic right ventricle.".

Manufacturer Narrative

The products were not returned for analysis.The lot history record (lhr) review and similar complaint review were not performed because this complaint was based on a review article, and no device/lot information was provided.Based on the limited information provided, a cause for the reported positioning failure could not be determined.It should be noted that the mitraclip g4 system instructions for use states under the "1.0 intended use" section that "the mitraclip g4 system is intended for reconstruction of the insufficient mitral valve through tissue approximation.¿ the reported off-label use was due to the user performing the mitraclip procedure on the tricuspid valve.Atrial flutter is listed in the instructions for use as a known possible complication associated with mitraclip procedures.A cause for atrial flutter could not be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP® SYSTEM 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: 16279355
• MDR Text Key: 308573107
• Report Number: 2135147-2023-00354
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2023

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male