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

Catalog Number UNK CDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Mitral Valve Stenosis (1965); Renal Failure (2041); Sepsis (2067); Heart Failure/Congestive Heart Failure (4446); Gastrointestinal Hemorrhage (4476)

Event Date 05/01/2014

Event Type  Death  

Manufacturer Narrative

The devices will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Death date, event date, and implant date: dates estimated.The udi number is not known as the part and lot number were not provided.The additional serious injury and malfunction reported in the article are captured under a separate medwatch report number.Article titled, "mitral valve surgery for persistent or recurrent mitral regurgitation after transcatheter edge-to-edge repair is associated with improved survival.".

Event Description

This research article was a retrospective study designed to highlight the potential of surgery as an option for high-risk patients who underwent transcatheter edge-to-edge repair and developed recurrent mitral regurgitation.Complications identified in the study included: single leaflet device attachment, difficult to remove, worsening mr, severe mitral stenosis, mitral valve replacement, gastrointestinal bleeding, sepsis, renal failure, postoperative atrial fibrillation, stroke, prolonged hospitalization due to heart failure, death.In conclusion surgical treatment of severe mr after mitral teer is feasible but requires mitral valve replacement.Compared with medical therapy, mitral surgery is associated with significantly lower risk-adjusted all-cause mortality during midterm follow-up.Details are listed in the attached article titled "mitral valve surgery for persistent or recurrent mitral regurgitation after transcatheter edge-to-edge repair is associated with improved survival".

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Additionally, the complaint history review was not performed because this incident was based on an article review and no lot information was provided.Based on available information, the cause of the reported mitral valve insufficiency/ regurgitation (worsening mr), mitral stenosis, hemorrhage (blood transfusion), sepsis, renal failure, atrial fibrillation, cerebrovascular accident, unrelated death, and heart failure/congestive heart failure (prolonged hospitalization) could not be determined.The cause of the reported incomplete coaptation could not be determined.The reported patient effects of mitral regurgitation, atrial fibrillation, sepsis, mitral stenosis, hemorrhage, renal failure, cerebrovascular accident, death, and heart failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported surgical intervention, hospitalization, and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B2, b3, d6: dates estimated d4: the udi number is not known as the part and lot number were not provided the additional serious injury and malfunction reported in the article are captured under a separate medwatch report number.

• 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: 15885740
• MDR Text Key: 304542236
• Report Number: 2135147-2022-02264
• Device Sequence Number: 1
• Product Code: NKM
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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?: No
• 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: 11/08/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 01/09/2023
• 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): Death
• Patient Age: 75 YR
• Patient Sex: Male