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); Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507)

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

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other implanted clips are filed under separate medwatch reports.

Event Description

This is filed to report the single leaflet device attachment (slda) and tissue damage.Clip delivery system (cds-71027u265) it was reported that on (b)(6) 2018, the patient, with grade 4 mixed mitral regurgitation and tethered leaflets underwent a mitraclip procedure.The first clip was successfully implanted.The second cds (80127u146) advanced.Some difficulty was noted attaching the clip to the leaflets due to the tethered leaflets.Leaflet insertion assessment was performed, and it was felt that both leaflets were well inserted and the clip was deployed.Immediately after clip deployment, it was noted that the clip had detached from the anterior leaflet, remaining attached to the posterior leaflet.A third cds (80103u146) was then advanced and the clip placed on the leaflets.The same issue occurred as with the previous clip; however, this clip immediately detached from the posterior leaflet, remaining attached to the anterior leaflet.A fourth cds (71027u265) was advanced and placed on the leaflets.The same issue occurred with the clip remaining attached only to the anterior leaflet.Tissue damage was noted, which was possibly due to the difficulty grasping.Echo was reviewed and it was felt that the 3rd and 4th clips had never been fully attached to both leaflets.The physician felt that during leaflet insertion assessment, he was actually seeing the first implanted clip and not the clip pending deployment.Visualization was difficult due to patient anatomy and the echosonographer.No additional intervention was performed.Mr remained unchanged at grade 4+.No additional information was provided.

Manufacturer Narrative

(b)(4).Failure to follow steps/instructions.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 known possible complications associated with mitraclip procedures.Additionally, the ifu instructs the user to rotate the delivery catheter (dc) handle to align the clip arms perpendicular to the line of coaptation.All available information was investigated and the reported difficult grasping appears to be due to the challenging patient anatomy (tethered leaflets) and user technique.The reported single leaflet device attachment (slda) appears to be primarily due to the user error of not confirming if the clip arms were perpendicular to the line of coaptation and due to the patients tethered leaflets.The mitral valve injury and unchanged mr appear to be related to the slda.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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7581037
• MDR Text Key: 110450357
• Report Number: 2024168-2018-04304
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

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: 10/28/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71027U265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 69