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

Catalog Number CDS0502

Device Problems Incomplete Coaptation (2507); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Tissue Damage (2104); Heart Failure (2206); Cardiac Tamponade (2226)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: estimated dates.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report tissue damage, heart failure, cardiac arrest, hypotension, hemorrhage, hypoxia, cardiac tamponade, and medical intervention.It was reported through a research article identifying mitraclip devices that were related to the following outcomes: tissue damage, heart failure, cardiac arrest, hypotension, hemorrhage, hypoxia, cardiac tamponade, and medical intervention.Details are listed in the attached article, titled, "acute complications of percutaneous mitral valve repair with mitraclip".No additional information was provided.

Manufacturer Narrative

D4: a partial udi is being reported because the lot number was not provided.The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the lot information regarding the complaint device was not provided.The investigation was unable to determine a cause for the respiratory distress, hemorrhage, heart failure, cardiac tamponade, tissue damage, cardiac arrest, hypotension.Respiratory distress, hemorrhage, heart failure, cardiac tamponade, tissue damage, cardiac arrest, and hypotension are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported additional therapy/non-surgical treatments were results 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 NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11163999
• MDR Text Key: 226595782
• Report Number: 2024168-2021-00395
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

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: CDS0502
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention