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); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the clip delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other clip delivery system (71102u168) is filed under a separate medwatch report number.

Event Description

This is filed to report the clip movement.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The first mitraclip (71103u159) was implanted medial, at a3/p3.The second clip delivery system (cds 71102u168) was advanced to the mitral valve.When advancing the clip to the left ventricle, the clip became caught on the chordae.Troubleshooting was performed and the clip was freed.There was no chordal damage.While retracting to the left atrium to reposition the clip, there was contact with the first clip implanted, and the first clip appeared to be loosened on one leaflet.The second clip was deployed to stabilize the first clip and for the mr reduction.Two clips were implanted, reducing mr to 1.It was noted that there was some shadowing from the guide during the procedure; however, this did not affect grasping and leaflet insertion.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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on the information provided the reported partial clip movement on the leaflet and device damaged by another device appear to be due to a combination of the medial prolapse, thickened leaflets and user technique/procedural circumstances.The poor image resolution issue was associated with some shadowing from the guide that was noted while visualizing the clip during the procedure.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
• 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: 7293321
• MDR Text Key: 100834795
• Report Number: 2024168-2018-01356
• 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: 05/02/2018

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: 11/04/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71103U159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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
• Treatment: STEERABLE GUIDE CATHETER, CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 55