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

Catalog Number CDS0502

Device Problems Failure To Adhere Or Bond (1031); Bent (1059); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The other clip delivery system is filed under a separate manufacturing report number.

Event Description

This report is filed for curving of the first clip delivery system.It was reported that this was a mitraclip procedure treating mixed, functional and degenerative, mitral regurgitation grade 3-4.Clip delivery system (cds0502/ 71004u152) attempted to grasp the anterior 3 leaflet (a3) and posterior 3 leaflet (p3) segment.During grasping attempts, the delivery catheter (dc) shaft had a curve, and it was difficult to grasp both leaflets due to this curve.Standard troubleshooting maneuvers were unsuccessful.The undeployed cds was removed without reported issue.Another cds (cds0502 71108u258) was used in replacement.After deployment of this clip, posterior medial leaflet detachment was observed (single leaflet device attachment-slda).Two mitraclips xtrs were implanted without reported issue and the mr was reduced to grade 1.There were no adverse patient effects.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).All available information was investigated and the reported delivery catheter (dc) shaft bends resulting in difficulty positioning the device was confirmed.The reported failure to adhere/bond could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified did not indicate a lot-specific quality issue.All available information was investigated and the reported dc shaft bent appears to be related to the observed bend in the actuator mandrel; however, definitive cause for the bent actuator mandrel could not be determined.The reported difficulty positioning the device (dc shaft positioning) and failure to adhere/bond was a secondary effect of the bent dc shaft.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: 7636125
• MDR Text Key: 112417989
• Report Number: 2024168-2018-04996
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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: CDS0502
• Device Lot Number: 71004U152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER