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

Catalog Number UNK CDS

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

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); Dyspnea (1816); Mitral Regurgitation (1964); Pulmonary Edema (2020); Weakness (2145); Heart Failure (2206)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The clip remains implanted 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 recurrent mitral regurgitation.It was reported that on (b)(6) 2013, a mitraclip procedure was performed to treat mitral regurgitation (mr).Two clips were successfully implanted.On (b)(6) 2019, the patient returned to the hospital with shortness of breath, congestive heart failure, atrial fibrillation, physical weakness, acute pulmonary edema and increased mr.In december of 2017, it was noted that the patient had significant bradycardia and underwent permanent pacemaker implantation.On (b)(6) 2019, the patient again returned to the hospital.Echocardiogram was performed and showed mr had increased to a grade of 3-4.The clips were confirmed stable on both leaflets; however, it was not reported on whether the increased mr and other symptoms were caused by progression of disease.No additional information provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number was not provided.It is possible that progression of the disease contributed to the reported difficulties however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of dyspnea, edema, atrial fibrillation, worsening heart failure and worsening mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8925633
• MDR Text Key: 155353866
• Report Number: 2024168-2019-11106
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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: 07/31/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 ADDITIONAL IMPLANTED MITRACLIP; 1 ADDITIONAL IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 97 YR
• Patient Weight: 65