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 Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 06/11/2018

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 additional relevant information.

Event Description

This is filed to report tissue damage and mitral valve replacement surgery.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the leaflets.The patient had a flail and leaflet grasping was difficult, but once grasped, the gradient was noted to be high.During removal of the cds, the clip became caught in the chordae and a chordal rupture and flail was noted.Due to the high gradient, the procedure was aborted.On (b)(6) 2018, the patient was taken to surgery for mitral valve replacement.Post-surgery, the patient was 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 that would have contributed to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported difficulty grasping appears to be related to patient morphology/pathology and due to leaflet flail.The reported difficulty removing the clip from the anatomy (chordae) appears to be due to a combination of patient anatomy and procedural circumstances of difficulty grasping.The tissue damage was likely a result of the clip becoming caught in the chordae (difficult to remove) and therefore, related to procedural circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, it was noted that during grasping, the clip became caught in the chordae.No additional information was provided.

• 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: 7640178
• MDR Text Key: 112413600
• Report Number: 2024168-2018-05066
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80105U274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Disability