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 Mitral Valve Stenosis (1965); Pulmonary Edema (2020); Respiratory Distress (2045)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event, tests, and implant: dates estimated.The udi is unknown as the part and lot number was not reported.Exemption number e2019001.The device was not returned for analysis.A review of the lot history record could not be performed as lot number was not provided.Based on the information reviewed, a conclusive cause for the reported mitral stenosis resulting in respiratory distress and pulmonary edema could not be determined in this incident.The hospitalization was result of case specific circumstances.The reported patient effects worsening mitral regurgitation (mr), mitral stenosis, respiratory distress and pulmonary edema are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report mitral stenosis, respiratory distress, pulmonary edema, and prolonged hospitalization.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr).In august, an unspecified number of clips were successfully deployed.Approximately two months later, the patient was re-admitted for respiratory distress and pulmonary edema as a result of a high pressure gradient of 15mmhg.Additional treatment was not performed.The physician is planning to explant the clips.No additional information was provided.

• Brand Name: MITRACLIP® SYSTEM 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: 9495616
• MDR Text Key: 175839365
• Report Number: 2024168-2019-14747
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/19/2019
• 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; Other