MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN MITRACLIP; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problem Anemia (1706)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

(udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information provided a conclusive cause for the reported anemia cannot be determined.The anemia is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.Initial results of combined mitraclip® implantation and left atrial appendage occlusion.

Event Description

This is filed to report anemia.It was reported through an article that a patient underwent a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips were successfully implanted without issues, reducing mr to a grade of 1.However, after the procedure, the patient had a progressive fall in hemoglobin level, which resulted in prolonged hospitalization.It was noted that no bleeding occurred.The patient was able to recover and was discharged from the hospital without further issues.Details are listed in the attached article, titled ¿initial results of combined mitraclip implantation and left atrial appendage occlusion.¿.

• Brand Name: UNKNOWN MITRACLIP
• 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: 11082826
• MDR Text Key: 224745548
• Report Number: 2024168-2020-10959
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 12/28/2020

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: 12/04/2020
• Initial Date FDA Received: 12/28/2020
• 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): Hospitalization
• Patient Age: 81 YR