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); Difficult To Position (1467)

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

Event Date 03/21/2018

Event Type  Injury  

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 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 is being filed to report difficult to position clip delivery system (cds) and leaflet damage.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.One clip was implanted and the mr remained at 3-4.The second cds was advanced to the mitral valve.While trying to grasp the leaflets with the second clip during the closing of the clip (grippers down) the delivery catheter (dc) moved backwards, while having the anterior and posterior leaflet attached to it which caused damage to the anterior leaflet.The cds was removed successfully and the procedure was aborted.One clip was implanted and mr remained at 3-4.The patient was confirmed to be stable post procedure.On (b)(6) 2018, the patient underwent mitral valve replacement surgery and 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 revealed no manufacturing nonconformities that would have contributed to this complaint.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 positioning the delivery catheter (dc) shaft and difficulty grasping (failure to adhere or bond to the leaflets) in this incident could not be determined.The reported patient effect of tissue damage appears to be a result of procedural conditions of difficulty grasping and difficulty positioning the cds, and the mitral regurgitation (mr) was a cascading effect of the tissue damage.The reported patient effects of mitral valve injury (tissue damage) and worsening mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.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: 7430315
• MDR Text Key: 105451312
• Report Number: 2024168-2018-02777
• 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
• Report Date: 07/02/2018

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: 12/01/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71130U102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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, 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention; Disability