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

Catalog Number CDS0602-NTR

Device Problem Knotted (1340)

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

Event Date 03/13/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip delivery system was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This event is filed for tissue damage, requiring intervention, and recurrent mitral regurgitation.It was reported that on (b)(6) 2018 this was a mitraclip procedure to treat grade 3-4 degenerative mitral regurgitation (mr).One mitraclip successfully grasped the leaflets reducing mr to grade 1.After the cap of the lock lever was removed and the lock line was unwrapped according to the instructions for use, a small knot was observed at the distal end of the lock line.The lock line was removed without incident by pulling on the side that had the knot.The clip was successfully deployed.Five days after the mitraclip procedure, on (b)(6) 2018, the patient had symptomatic mr grade 4.The clip was stable at the medial position but there was a perforation observed in the anterior mitral leaflet (aml).The perforation was located between the tip of the anterior clip arm and the anterior annulus.On (b)(6) 2018 a ventricular septal occluder (12mm) was successfully implanted to treat the aml perforation.Mr severity was reduced to grade 3-4 with the occluder.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: this incident was further reviewed by an abbott vascular medical affairs director.The reviewer stated that, limited information is available to understand when the patient condition started to deteriorate and lead to multi-organ failure ultimately resulting in death.It seems that the anterior leaflet perforation was the starting point and the cause of this perforation does not seem to have been directly caused by the device during the index procedure.As it appeared secondarily following an initially successful procedure, it may have been due to excessive tension on the tissues leading to leaflet tear.Death was a complication of the second procedure aiming at repairing aml perforation with a heart occluder.The mitraclip procedure may have contributed to the cascade of events leading to the fatal outcome but there is no evidence of a direct relationship with the device.All available information was investigated and the reported knotted lock line issue was confirmed during returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of worsening mitral regurgitation (mr), death and mitral valve injury (tissue damage) as listed in the mitraclip ntr/xtr system instructions for use, are known possible complications associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported knotted lock line could not be determined in this incident.Additionally, a definitive cause of the reported tissue damage could not be determined in this incident and was possibly due to procedural conditions; however, the reported recurrent mitral regurgitation (mr) and death were likely a symptom of tissue damage.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previously filed report, additional information was received that the patient expired on (b)(6) 2018 from multiple organ failure.In the opinion of the physician, the mitraclip may have contributed to the death.There was no additional information provided.

• 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: 7400813
• MDR Text Key: 104530472
• Report Number: 2024168-2018-02498
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2018
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 71214U179
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• 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
• Patient Outcome(s): Death; Required Intervention