MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0502

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Fatigue (1849); Mitral Regurgitation (1964); Weakness (2145); Heart Failure (2206)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimated.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 filed to report the single leaflet device attachment (slda) and increased mitral regurgitation (mr) with heart failure.It was reported that the initial mitraclip procedure was performed on (b)(6) 2018, to treat degenerative mr with a grade of 2-3.One clip (80614u125) was successfully implanted, reducing the mr to 1.Approximately 2-3 weeks post procedure, the patient suddenly experienced heart failure symptoms, including shortness of breath, weakness and fatigue.Echocardiogram was performed which noted the clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda) and the mr increased to 2-3.On (b)(6) 2019, a second procedure was performed for treatment.Two clips were implanted to stabilize the slda clip, one clip each on the medial and lateral side of slda and the mr was reduced to 1.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history records identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history revealed no indication of a lot specific product issue.All available information was investigated and a definitive cause for the single leaflet device attachment (slda) in this incident could not be determined.The reported dyspnea, heart failure, fatigue and recurrent mitral regurgitation (mr) appears to be cascading effects of the sdla as the patients mr had increased to grade 2-3.The reported patient effects of dyspnea, worsening mr and worsening heart failure are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8637456
• MDR Text Key: 145972730
• Report Number: 2024168-2019-04060
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80614U125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention