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

Catalog Number CDS0602-NTR

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

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the suspected allergic reaction.It was reported that the mitraclip procedure was performed on (b)(6) 2020, to treat grade 3-4 functional mitral regurgitation (mr).One clip was implanted, reducing mr to <1.On (b)(6) 2020, three-days post clip implantation, the patient developed a fever with chills and increased c-reactive protein (crp).Antibiotics were given for the fever.The physician suspects an allergic reaction occurred and that the mitraclip device could have caused or contributed to the fever and suspected allergic reaction.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effect of fever and allergic reaction (hypersensitivity) as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported hypersensitivity (allergic reaction) appears to be due to procedural conditions and the reported fever appears to be a result of the reported hypersensitivity.There is no indication of a product quality issue with respect to manufacture, design or labeling.B2: hospitalization was added.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10099145
• MDR Text Key: 193068909
• Report Number: 2024168-2020-04586
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

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: 10/20/2020
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 91019U148
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/01/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention