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

Catalog Number CDS0502

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

Patient Problems Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Renal Failure (2041); Weakness (2145); Test Result (2695)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of hematoma, hypersensitivity, weakness, renal failure and test result as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The investigation was unable to determine a conclusive cause for the hematoma, renal failure and hypersensitivity.The reported weakness and test results appear to be cascading effects of the renal failure.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report the allergic reaction.It was reported that the initial mitraclip procedure was performed on (b)(6) 2019 to treat functional mitral regurgitation (mr) with an mr grade of 3-4.One clip was implanted, reducing mr to 1.On (b)(6) 2020, the patient acquired von willebrand syndrome, manifested as generalized purpura and epistaxis lasting > 1 day.Steroids were provided for treatment.On (b)(6) 2020, the patient presented with unexplained muscle weakness and renal impairment and was readmitted to the hospital from the rehabilitation hospital.Test results showed hypoalbuminemia, positive direct coombs, increased eosinophils, and increased immunoglobulin e (ige).Per the physician the possibility of allergy caused by the mitraclip device cannot be ruled out as a cause of eosinophilia or ige elevation.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• 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: 9980009
• MDR Text Key: 189706144
• Report Number: 2024168-2020-03776
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2020

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 Expiration Date: 06/30/2020
• Device Catalogue Number: CDS0502
• Device Lot Number: 90629U183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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: 70 YR
• Patient Weight: 43