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

Catalog Number UNK CDS

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Additionally, the complaint history review was not performed because this incident was based on an article review and no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported slda, expulsion, death, embolism, heart failure, cerebrovascular accident, cardiac arrest, perforation, tissue injury, bleeding, arrythmia, and mitral regurgitation were unable to be determined.The reported patient effects of death, embolism, arrhythmia, hemorrhage, perforation of vessels, tissue injury, cerebrovascular accident, mitral regurgitation, and heart failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported surgical intervention, unexpected medical intervention, and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: article titled "contemporary experience of mitral transcatheter edge, catheterization and cardiovascular interventions.

Event Description

The article "contemporary experience of mitral transcatheter edge, catheterization and cardiovascular interventions" was reviewed.The article presented a retrospective multi center study, to evaluate the impact of mitral annular calcification (mac) on the procedural durability and success of newer generation mitraclip systems (g3 and g4 systems).Devices mentioned included generation three and four mitraclip systems.The article concluded that contemporary mitral transcatheter edge-to-edge repair (m-teer) is safe, and procedural success is similar to patients with none-mild mac.However, a loss of procedural durability was seen in +mac group at 1-year follow-up.[the primary author and corresponding author was dr.Ahmad mustafa, department of cardiovascular and thoracic surgery, northwell health, new hyde park, new york with the corresponding email: amustafa3@northwell.Edu.] the time frame of the study was july 2018 to july 2022.A total of 260 patients were included in this study, of which all received an abbott device.The average age of the patients enrolled was 79.1.The majority gender was female.As this is from a literature review, patient weight was not provided.Comorbidities included: atrial flutter, atrial fibrillation, cardiomyopathy, carotid artery stenosis, cerebrovascular accident, chronic lung disease, diabetes mellitus, heart failure, hypertension, myocardial infarction, peripheral artery disease, dialysis dependent, tobacco use, aortic stenosis, aortic insufficiency.Intra, peri and post-procedural complications included: single leaflet device attachment, device embolization, atrial fibrillation, bleeding, surgical intervention, unexpected medical intervention, permanent pacemaker placement, minor vascular complications, mitral valve injury (tissue injury), cardiac arrest, cerebrovascular accident, death, heart failure, hospitalization, recurrent mr.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18956054
• MDR Text Key: 338431987
• Report Number: 2135147-2024-01316
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• 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