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

Catalog Number CDS02ST

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Mitral Regurgitation (1964)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This report is filed since the implanted mitraclip partially detached from one leaflet.It was reported that on (b)(6) 2016, a mitraclip (cds0502 51030u159) was implanted without reported issue reducing the mitral regurgitation (mr) from grade 4 to 1.On (b)(6) 2018, during a follow-up visit, the mitraclip was noted partially detached from the anterior leaflet, while remaining attached to the posterior leaflet.On (b)(6) 2018, another procedure was performed for degenerative mitral regurgitation, grade 3-4.One mitraclip was implanted without reported issue, reducing the mr to grade no additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number: (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Correction: catalog number.Correction: on the initial, 30 day medwatch report, the date was incorrect.The correct date should have been (b)(6) 2018.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effect of worsening mitral regurgitation (mr), as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported difficulty grasping appears to be related to patient morphology/pathology (pre-existing flail).The reported worsening mr was a result of patient/procedural conditions and due to the possible clip movement on the leaflets.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial medwatch report, the additional information was received: the patient presented at the index procedure with leaflet flail.Reportedly, the partial leaflet detachment was most likely due to pre-existing anatomy and leaflet flail, although this could not be certain.There was no evidence of tissue damage.

• 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: 7626468
• MDR Text Key: 111941213
• Report Number: 2024168-2018-04792
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: CDS02ST
• Device Lot Number: 51030U159
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention