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

Catalog Number UNK CDS

Device Problems Incomplete Coaptation (2507); Expulsion (2933)

Patient Problems Angina (1710); Bradycardia (1751); Embolism (1829); Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Myocardial Infarction (1969); Shock (2072); Tissue Damage (2104); Ventricular Tachycardia (2132); Heart Failure (2206); Cardiogenic Shock (2262)

Event Date 01/01/2016

Event Type  Death  

Manufacturer Narrative

Estimated dates.Exemption number (b)(4).The device was not returned for analysis.Additionally, a review of the lot history record and complaint history for the reported lot could not be conducted, because the lot number and serial number were not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.All available information was investigated and a definitive cause for the reported single leaflet device attachment/slda could not be determined in this incident; however, the reported complete clip detachment (ccd) was due to slda.The reported embolism and ischemia appear to be due to the reported expulsion.Based on this information, the reported patient effects as reported within this complaint is a combination of challenging patient anatomy and post procedural outcome/cascading events.The cause of death is due to cardiogenic shock that resulted in multi organ failure.The reported patient effects of angina, myocardial infarction, cardiogenic shock, emboli, mitral regurgitation, death, hypotension and mitral valve injury (tissue damage) as listed in the mitraclip system instructions for us, are a known possible complication associated with mitraclip procedures.This event was further reviewed by an abbott vascular medial affairs director and the reviewer stated that: the death was not directly related to the device, but the clip detachment led to a cascade of events ultimately resulting in death.There is no indication of a product issue with respect to manufacture, design or labeling.The other additional devices referenced are being filed under a separate medwatch report number.

Event Description

This is being filed to report clip deployment difficulty, single leaflet device attachment/slda, clip detachment, myocardial infarction, tissue damage, ventricular tachycardia, bradycardia, heart failure, medical intervention, prolonged hospitalization and death.It was reported through a research article identifying a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4.It was noted coronary artery disease, moderate aortic stenosis, atrial fibrillation, hypertension, and moderately reduced left ventricular systolic function.The first clip delivery system (cds ¿ clip one) was advanced to the mitral valve, and the clip was placed; however, there was difficulty grasping due to pre-existing flail.The clip was deployed in the a2/p2 position, reducing mr.Then a second clip (clip two) was placed in the lateral position, and the clip was deployed.However, upon clip deployment of the second clip, both the first clip and the second clip became detached from one leaflet but remained attached to the other leaflet (single leaflet device attachment/slda), increasing mr back to 4.Reportedly, clip one and clip two had clip deployment difficulties.A third clip (clip three) was deployed to stabilize the slda of clip one and clip two, reducing mr.Three clips were implanted, reducing mr to 1.Approximately six weeks later, the patient returned with chest pain, myocardial infarction, shock, hypotension.Imaging revealed that clip three became completely detached resulting in tissue damage.Both slda clips were still partially detached from one of the leaflets.It was suspected that the clip three had partially detached from the posterior leaflet initially.The patient was emergently intubated and transferred to the laboratory.The patient had bradycardia which was treated with a temporary pacemaker.Initial attempts to snare the dislodged clip were unsuccessful.The clip had embolized from the ostium of the right coronary artery (rca) to the cusp of the rca.A 25mm gooseneck snare was introduced, and the clip was successfully snared to the right common femoral artery.A surgical cut-down was performed, and the clip was retrieved.The patient developed sustained ventricular tachycardia requiring defibrillation.An intra-aortic balloon pump was placed for hemodynamic stabilization and the patient was admitted to the intensive care unit with severe mr and a small atrial septal defect.The patient was experiencing heart failure symptoms.The patient went into cardiogenic shock and multi-organ failure and died two days later.Specific patient information is documented as unknown.Details are listed in the article, titled "late mitraclip embolization a new cause of st-segment¿elevation myocardial infarction¿no additional information was provided.

• 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: 9336328
• MDR Text Key: 166815533
• Report Number: 2024168-2019-13698
• 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: 07/23/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER.; TWO IMPLANTED MITRACLIPS.; STEERABLE GUIDE CATHETER; TWO IMPLANTED MITRACLIPS
• Patient Outcome(s): Death
• Patient Age: 80 YR