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

Catalog Number CDS0602-XTR

Device Problems Failure To Adhere Or Bond (1031); Knotted (1340); Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The gripper line was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The mitraclip xtr is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

This is filed to report the difficulty removing the gripper line, clip movement and leaflet damage.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 2.The clip delivery system (cds) was advanced to the mitral valve.During the grasping attempts, the clip became caught in the chordae.The clip was inverted and retracted; however, the chordae may have been damaged.The leaflets were grasped, and the deployment sequence was started.It was noted that the gripper line had a knot or kink which prevented the polyimide tubing from being removed from one proximal end of gripper line.The gripper line was able to be removed by pulling the end with the knot/kink.The physician commented that he was not sure if he had caused the knot or if it was there at the beginning.After the clip was deployed, it was observed that the clip was unstable, and a leaflet tear was suspected.An additional clip was implanted for stabilization.Two clips were implanted, reducing mr to 1.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: only the gripper line of the clip delivery system (cds) was returned and a knot was visible at one end.A review of the lot history record identified no manufacturing nonconformities associated with the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other incidents reported from this lot.The reported patient effect of tissue damage (mitral valve injury), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information and without the returned device, a definitive cause for the reported knotted gripper line could not be determined.The reported difficulty removing the gripper line was a secondary effect of the knot.The reported failure to adhere or bond appears to be related to challenging patient anatomy.The reported patient effect of tissue damage appears to be related to procedural conditions as multiple grasping attempts were made.There is no indication of product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR 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: 7426143
• MDR Text Key: 105313369
• Report Number: 2024168-2018-02727
• 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: 04/23/2018

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: 12/20/2018
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 71220U151
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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
• Patient Outcome(s): Required Intervention