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

Catalog Number CDS0501

Device Problems Failure To Adhere Or Bond (1031); Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964)

Event Date 05/25/2018

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 the cds was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the single leaflet device attachment (slda).It was reported that the initial mitraclip procedure was performed on (b)(6) 2018 to treat degenerative mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the mitral valve and during grasping there was some difficulty as the posterior leaflet was thin, but the clip was successfully implanted, reducing the mr to 1.On (b)(6) 2018, the following day, the patient experienced shortness of breath and was not feeling well.An echocardiogram was performed, which found that the clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda).The mr had increased to 4.There was no evidence of chordal rupture or tissue damage.On (b)(6) 2018, two additional clips (lot# 80403i148 and 80403u149) were implanted for stabilization and mr was reduced from 4 to 2.No additional information was provided.

Manufacturer Narrative

(b)(4).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 identified no similar incidents reported from this lot.All available information was investigated and the reported single leaflet device attachment (slda) and difficulty grasping the leaflets appear to be related to patient morphology/pathology (thin posterior leaflet).The reported adverse event of worsening mitral regurgitation (mr) was a result of the slda, and the reported dyspnea was likely the secondary effect of the worsened mr.The reported patient effects of mr and dyspnea, as listed in the mitraclip system instructions for use, is a known possible complication 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: 7616050
• MDR Text Key: 111620367
• Report Number: 2024168-2018-04634
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

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: 03/28/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80327U161
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 97