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

Catalog Number UNK CDS

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

Patient Problems Arrhythmia (1721); Fistula (1862); Tachycardia (2095); Ventricular Fibrillation (2130); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/01/2009

Event Type  Injury  

Event Description

This is being filed to report the fistula, arrhythmia, tachycardia, ventricular fibrillation, mitral regurgitation and intervention.The aim of the study was to assess the impact of teer using the mitraclip device on the burden of va and icd therapies.Complications identified were periprocedural partial clip detachment during placement of a second mitraclip device, requiring a third mitraclip for stabilization, arterio-venous fistula observed requiring surgical repair, ventricular arrhythmia, ventricular fibrillation, intervention, recurrent mr.The results of the study suggest that teer results in a significant reduction of ventricular arrhythmias and icd therapies in advanced hf patients.These effects were more prominent in patients presenting with non-ischaemic cardiomyopathy, higher baseline nyha functional class and larger lv dimensions.While teer did reduce va burden, it did not result in improved two-year survival in this advanced hf cohort.Specific patient information is documented as unknown.Details are listed in the attached article, titled impact of percutaneous mitral valve repair using the mitraclip system on ventricular arrhythmias and icd therapies.No additional information was provided.

Manufacturer Narrative

The clips remains in patients.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.Event date: estimated dates.The udi number is not known as the part and lot number were not provided.The additional deaths and malfunctions reported in the article are captured under separate medwatch reports.Attachment: article titled, "impact of percutaneous mitral valve repair using themitracliptm system on ventricular arrhythmias andicd therapies".

Event Description

N/a.

Manufacturer Narrative

The device was not returned for analysis.The devices were not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.A cause for the reported patient effects of arrhythmia, tachycardia could not be determined.The mr was resulted from reported single leaflet device attachments.Additionally, the reported patient effects fistula, arrhythmia, tachycardia, ventricular fibrillation, and mr are as listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Lastly, the reported surgical intervention and unexpected medical 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® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 14135415
• MDR Text Key: 289436932
• Report Number: 2024168-2022-04107
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/14/2022
• 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; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male