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 Inflammation (1932); Respiratory Distress (2045); Tachycardia (2095)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Dates of event, tests, and implant: dates estimated.The device was not returned for analysis.A review of the lot history record could not be performed as the lot number/part number information was unavailable.Based on the information reviewed, a definite cause for the reported inflammation, tachycardia and respiratory distress could not be determined.It is possible that these were related to the patient¿s condition and/or the procedural conditions, but this cannot be conclusively determined.The reported patient effects of inflammation, tachycardia and respiratory distress, 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.

Event Description

This is filed to report inflammation.It was reported that on an unknown date, a mitraclip procedure was performed to treat mitral regurgitation (mr).One mitraclip was successfully implanted and the patient¿s condition was good.However, after some time the patient suffered from a swollen abdomen, difficulty breathing and an increased heart rate.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: 9717415
• MDR Text Key: 180727744
• Report Number: 2024168-2020-01536
• 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: 02/17/2020

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: 01/28/2020
• Initial Date FDA Received: 02/17/2020
• 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): Other