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

Catalog Number CDS0602-XTR

Device Problem Incomplete Coaptation (2507)

Patient Problems Cardiac Enzyme Elevation (1838); Mitral Regurgitation (1964); Heart Failure (2206)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.On (b)(6) 2019: creatine kinase (ck)=24 iu/l, normal upper limit 195.On (b)(6) 2019: troponin i=50.3 ng/ml, upper reference limit 14.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 report is filed as the clip detached from the posterior leaflet and the patient was hospitalized for worsening mitral regurgitation and congestive heart failure.It was reported that on (b)(6) 2019, the patient presented with degenerative mitral regurgitation (mr) grade 4+, with an anterior leaflet 2 (a2) prolapse, primary jet a2p2, and mitral annular calcification.Reportedly, the patient possibly had friable leaflets.One mitraclip was implanted at the a2p2 without a device deficiency.The mr was reduced to grade 2+ and the patient was discharged from the hospital.On (b)(6) 2019, per echocardiography,the mr had increased to grade 4+.The clip had detached from the posterior leaflet, while remaining attached to the anterior leaflet (single leaflet device attachment-slda).On (b)(6) 2019, the patient was hospitalized for worsening congestive heart failure.Elevated troponin was observed.As treatment, the furosemide medication was increased and another mitraclip procedure was performed on (b)(6) 2019, with implantation of a second mitraclip.No additional information was provided regarding this issue.

Event Description

Subsequent to the previous report, additional information received: the worsened heart failure resolved and the patient was discharged from hospital on (b)(6) 2019.

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 lots that would have contributed to the reported event.Additionally, a review of the complaint history revealed no indication of a lot specific product issue.It should be noted that the reported patient effect of worsening mitral regurgitation (mr) and heart failure, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported single leaflet device attachment (slda), enzyme elevation, recurrent mr and heart failure could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8670622
• MDR Text Key: 147058222
• Report Number: 2024168-2019-04423
• 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: foreign,health professional,s
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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: 01/15/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 90114U167
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 47