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

Catalog Number CDS0501

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the clip delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other clip delivery system (70925u361) is filed under a separate medwatch report number.

Event Description

This is filed to report the clip movement.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The first clip delivery system (cds 70925u361) was advanced to the mitral valve.The clip was deployed, reducing the mr to 2+.After deployment, the clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda).The mr returned to 4+.The second cds (71004u218) was advanced to the mitral valve, and the clip was positioned lateral for stabilization of the slda clip.The second clip was implanted, reducing the mr to 2+.A third cds was attempted, but was unsuccessful, and was removed without issue.It was then noted that the second clip was unstable, but still attached to both leaflets.The mr was 3-4+.No further treatment was attempted.Two clips were implanted, reducing the mr to 3-4+.The patient remained stable and a surgical consult is planned.Per the physician, the slda was most likely due to the fragile posterior leaflet.No additional information was provided.

Manufacturer Narrative

(b)(4).The clip remains implanted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the reported clip movement appears to be related to patient morphology/pathology as the patient had fragile and prolapsed leaflet.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

• 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: 7232444
• MDR Text Key: 98998329
• Report Number: 2024168-2018-00725
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71004U218
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER, 1 IMPLANTED MITRACLIP
• Patient Age: 42 YR
• Patient Weight: 88