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 Problems Dyspnea (1816); Edema (1820); Mitral Valve Stenosis (1965); Heart Failure (2206)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the patient was re-hospitalized for dyspnea, water storage [edema] and mitral stenosis and heart failure.It was reported that the index mitraclip procedure was performed in (b)(6) 2017.After some time the patient was re-hospitalized for dyspnea, water storage [edema] and mitral stenosis due to heart failure.Reportedly, the clip remained stable on both leaflets.No additional information was provided.

Manufacturer Narrative

B3: date of event estimated.D6: date of implant estimated.The device was not returned for analysis.A review of the lot history record could not be performed due to unknown lot information.Based on the information reviewed, a conclusive cause for the reported heart failure cannot be determined.Edema, mitral stenosis and dyspnea were due to the heart failure.The reported hospitalization was a result of case-specific circumstances.The reported patient effects of mitral stenosis, heart failure, dyspnea, and edema as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: UNKNOWN MITRACLIP
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9883543
• MDR Text Key: 188405438
• Report Number: 2024168-2020-02933
• 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: 04/13/2020

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
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization