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); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problems Tricuspid Regurgitation (2112); Foreign Body In Patient (2687)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

The patient and device codes were coded by the manufacturer.(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: steerable guide catheter, 1 additional implanted mitraclip.(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 device referenced is filed under a separate medwatch report.

Event Description

This is filed to report that the clip entanglement in the chordae.It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 4.The first clip (70731u380) was implanted between the posterior/septal leaflets and the tr remained at 4.The decision was made to implant a second clip (70823u102) on the posterior/septal leaflets.During several grasping attempts were made and the clip became entangled on the chordae of the lateral wall of the tricuspid valve.Standard troubleshooting was performed in an attempt to release the clip from the chordae, but this was unsuccessful.Due to the maneuvers, the first clip detached from the posterior leaflet and remained attached to the septal leaflet (single leaflet device attachment/slda).The second clip could not be removed from the chordae; therefore, it was deployed on the chordae in order to remove the clip delivery system (cds).After deployment of the second clip, it was confirmed that the first clip was stable on the septal leaflet and the second clip was stable on the posterior chordae.The tr remained at 4, and the patient was confirmed to be stable.Is still severe (4).Patient is stable.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 identified no similar incidents reported from this lot.All available information was investigated, and a definitive cause for the reported difficulty grasping cannot be determined.The difficulty grasping resulted in the clip becoming caught on the chordae.The reported patient effects of foreign body in patient and tricuspid regurgitation appear to be related to the procedural circumstances of the clip becoming entangled in the chordae and thus not being able to implant the clip at the intended location.It should be noted that the mitraclip nt system instructions for use states the mitraclip nt system is intended for reconstruction of the insufficient mitral valve through tissue approximation.Based on the information reviewed, 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: 7135308
• MDR Text Key: 95401305
• Report Number: 2024168-2017-09992
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

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: 08/23/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70823U102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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; Required Intervention