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

Event Date 04/11/2018

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 relevant information.The additional mitraclip (71027u113) device is being filed under separate medwatch report.

Event Description

This is filed to report the chordal damage and worsened mitral regurgitation (mr).It was reported that the initial mitraclip procedure was performed in (b)(6) 2018 to treat a mr with a grade of 4.One mitraclip (71027u113) was implanted, reducing the mr to 1.Earlier in the month of (b)(6), the patient presented with worsening heart failure symptoms with increase mr with a grade 3+.The clip was securely attached; however, a flail was noted due to a chordal rupture lateral to the initial clip.The patient remained hospitalized.On (b)(6) 2018, a second mitraclip procedure was performed in an attempt to treat the flail.The clip delivery system (cds 80103u269) was advanced to the mitral valve, but grasping was difficult due to the patient anatomy and image quality.During grasping, an additional chordal damage occurred.The clip was then implanted successfully medial to the first clip.An atrial septal occluder (aso) was attempted to plug the lateral commissure, but was unsuccessful and resulted in additional chordal damage.The mr increased to 4+.It is unknown what the next steps of therapy will be at this time.No additional information was provided.

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 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 failure to bond (difficulty grasping the leaflets) and poor image resolution appears to be a combination of the challenging patient morphology/pathology (flail posterior leaflet) and procedural circumstances (visualization).The reported mitral valve injury (tissue damage) appears to be a cascading effect of the difficulty grasping the leaflets.The reported recurrent mitral regurgitation (mr) appears to be a result of procedural conditions/cascading effect of the mitral valve injury.The reported patient effects of worsening mr and tissue damage as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.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: 7483925
• MDR Text Key: 107258952
• Report Number: 2024168-2018-03262
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

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: 01/04/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80103U269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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
• Treatment: STEERABLE GUIDE CATHETER1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR