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

Catalog Number UNK CDS

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

Patient Problems Anemia (1706); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); Sepsis (2067); Transient Ischemic Attack (2109); Heart Failure (2206); Cardiac Tamponade (2226); Respiratory Failure (2484)

Event Date 02/01/2014

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.The unique device identifier (udi) is unknown because the parts and lot numbers were not provided.Implant date: estimated.The clips remain 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.The reported patient deaths referenced are filed under a separate medwatch report number.Literature: "association of baseline kidney disease with outcomes of transcatheter mitral valve repair by mitraclip.".

Event Description

This is filed to report the serious injuries.It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, stroke, hemorrhagic stroke, respiratory failure, atrial fibrillation, sepsis, anemia, pneumonia, bleeding, worsening heart failure, acute kidney injury, cardiac tamponade, re-hospitalization and medical intervention.Details are listed in the attached article, titled ¿association of baseline kidney disease with outcomes of transcatheter mitral valve repair by mitraclip.¿.

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history records could not be performed as the part and lot information was not provided.The reported patient effects of transient ischemic attack, atrial fibrillation, septicemia, worsening heart failure, cardiac tamponade, stroke, respiratory failure, hemorrhage requiring transfusion, renal failure and additional therapy/non-surgical treatment, as listed in the mitraclip ntr/xtr system instructions for use, are known possible complications associated with mitraclip procedures.Based on the limited information, a definitive cause for the reported transient ischemic attack, atrial fibrillation, sepsis, anemia, worsening heart failure, cardiac tamponade, stroke, respiratory failure, hemorrhage, renal failure, hospitalization and additional therapy/non-surgical treatment cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10454881
• MDR Text Key: 204409719
• Report Number: 2024168-2020-07121
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 77 YR