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 Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Myocardial Infarction (1969); Renal Failure (2041); Thrombosis (2100); Tissue Damage (2104); Pseudoaneurysm (2605); Pericardial Effusion (3271)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date: estimated.The devices were not returned for analysis.A review of the lot history records could not be performed due to unknown lot information.Additionally, a review of the complaint histories could not be performed due to unknown lot information.The reported patient effects of kidney failure, mitral stenosis, thrombosis, chordal rupture, pericardial effusion, hematoma, pseudoaneurysm, hemorrhage, unchanged mitral regurgitation, hypotension, myocardial infarction, and stroke are listed in the mitraclip system instructions for use, and are known possible complications associated with mitraclip procedures.A cause for the reported patient effects of kidney failure, mitral stenosis, thrombosis, chordal rupture, pericardial effusion, hematoma, pseudoaneurysm, hemorrhage, unchanged mitral regurgitation, hypotension, myocardial infarction, and stroke could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The patient effects of death and device issues mentioned and in the attached article are filed under other mfr report numbers.Literature title: acute kidney injury after percutaneous edge-to-edge mitral repair.

Event Description

This is filed to report serious injuries.It was reported through a research article identifying the mitraclip that may be related to the following: patient deaths, kidney failure, mitral stenosis, thrombosis, chordal rupture, pericardial effusion, hematoma, pseudoaneurysm, hemorrhage, unchanged mitral regurgitation, hypotension, myocardial infarction, stroke, re-hospitalization, medical intervention and surgical intervention.Device issues include, single leaflet device attachment (slda) and clip entrapment.Details are listed in the attached article, titled ¿acute kidney injury after percutaneous edge-to-edge mitral repair.".

• Brand Name: MITRACLIP 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: 11041865
• MDR Text Key: 222662039
• Report Number: 2024168-2020-10735
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/18/2020
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 72 YR