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

Catalog Number CDS0502

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This report is filed since a leaflet tear was observed following leaflet grasping.It was reported that this was a mitraclip procedure treating severe functional mitral regurgitation grade 4 with posterior leaflet restriction and annulus dilatation.The clip grasped the anterior leaflet 2 (a2) and posterior leaflet 2 (p2) leaflets without issue, reducing the mr.A still significant jet remained lateral to the mitraclip.It was decided to grasp more lateral towards the jet.The second grasping was performed without issue; however, a new eccentric jet was observed.The mr had increased-back to grade 4 and the posterior leaflet was no longer observed going over the clip arm.A leaflet tear was suspected.Other grasping attempts were performed; however, mr was unable to be reduced.The leaflet tear was confirmed at the mid p2 leaflet.The procedure was aborted; no clip was implanted and mr remained grade 4.The patient underwent surgical mitral valve replacement and was in stable condition post-operatively.No additional information was provided regarding this issue.

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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of worsening mitral regurgitation (mr) and mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use (ifu) are a known possible complication associated with mitraclip procedures.All available information was investigated and the reported failure to adhere/bond appears to be related to patient morphology/pathology (restricted posterior leaflet and dilated annulus).However, the reported tissue damage appears to be due to user technique/procedural circumstances as it was noted that maneuvering of the device resulted in the mitral valve injury; the unchanged mr appears to be due to the reported failure to adhere/bond as tissue damage occurred and mr remain unchanged.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: 7571809
• MDR Text Key: 110166569
• Report Number: 2024168-2018-04177
• 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: 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: 03/06/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80306U223
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Disability