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).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 additional relevant information.

Event Description

This is filed to report the sleeve steering issues.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The clip delivery system (cds) was advanced to the mitral valve.Grasping was performed and noted to be difficult.After trying to grasp the leaflets approximately 6 times, a curve was noted in the cds steerable sleeve shaft.Tension was released with the delivery catheter (dc) handle; however, the curve was still visible when attempting to steer toward the mitral valve.The curve appeared worse when unlocking the clip.The decision was made to discontinue the procedure at this time.Another procedure will be attempted at a later date.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and investigated.The reported delivery catheter (dc) shaft bend and difficulty positioning the device were confirmed.The reported failure to adhere or 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 revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the dc shaft bend.The reported difficulty positioning the dc shaft and reported difficulty grasping the leaflets was a result of the procedural circumstances/secondary effect of the bent dc shaft.Based on the information reviewed, 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: 7634814
• MDR Text Key: 112417315
• Report Number: 2024168-2018-04957
• 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: 09/05/2018

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: 01/08/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80106U188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER