MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP NTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0602-NTR

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 06/05/2018

Event Type  Injury  

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 relevant information.

Event Description

This report is filed since the mitraclip was difficult to remove and tissue damage occurred.It was reported that this was a mitraclip procedure treating degenerative mitral regurgitation (mr) grade 4.The patient presented with a complex anatomy and a big flail at the medial commissure site.A low transeptal puncture was performed due to a small left atrium, 3.3mm distance from the puncture the leaflet coaptation area.Following, mitraclip (cds0602-ntr 80207u155) attempted to grasp both leaflets at the medial commissure; however, it was not possible to grasp both leaflets.The device was slightly repositioned in the ventricle but the leaflets were unable to be grasped.The operator decided to not implant this device and remove it from the patients anatomy.During removal and due to the small anatomy, the mitraclip was difficult to remove from the mitral valve.The physician attempted to invert the clip and remove, however due to these maneuvers, the clip became stuck at the lateral commissure and a torn chorda occurred following.Standard troubleshooting was performed and the mitraclip was eventually removed from the patients anatomy.Another mitraclip with longer clip arms, mitraclip xtr, was successfully implanted, reducing the mr to grade 2-3.There was no adverse patient sequela due to this issue and no clinically significant delay.No treatment was provided due to this issue.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The mitraclip ntr device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.

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 that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.It should be noted that the reported patient effect of mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported failure to adhere or bond and difficult to remove appears to be due patient morphology/pathology as the patient presented with a complex anatomy and a big flail at the medial commissure site.Additionally, undeployed clip was difficult to remove due to small anatomy.Lastly, the reported tissue damage appears to be due to the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filled medwatch report, additional information was obtained: a low transseptal puncture was performed due to a very small left atrium, 3.3cm (not 3mm) distance between the transseptal puncture site and the coaptation area of the leaflets.

• Brand Name: MITRACLIP NTR DELIVERY SYSTEM
• 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: 7630712
• MDR Text Key: 112073448
• Report Number: 2024168-2018-04860
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2019
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 80207U155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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 CATHETER
• Patient Outcome(s): Other