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

Catalog Number CDS0502

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Damage (2104)

Event Date 12/07/2017

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 will not be returned.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the tissue damage.It was reported that on (b)(6) 2017, the patient, with functional mitral regurgitation (mr), underwent a mitraclip procedure, treating mr of grade 4.Patient anatomy included a large left atrium and left ventricle, as well as a restricted posterior (p) leaflet at the p2 leaflet segment.Coaptation was noted to be poor.Two clips were implanted, the first centrolateral, and the second in a central position.A third clip was attempted to be placed; however, due to the poor coaptation, difficulty was noted during grasping.The clip was unable to grasp the leaflets and the posterior leaflet was damaged at the centromedial position.The third clip was not implanted, and after two clips were implanted, the mr grade was reduced to grade 3.No intervention was performed to treat the damaged posterior leaflet.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 event.Additionally, a review of the complaint history identified no similar incidents from the lot.The reported patient effect of mitral valve injury as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported difficulty grasping the leaflets appears to be related to patient morphology/pathology.The reported tissue damage appears to be related to procedural circumstances of difficulty grasping.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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: 7151474
• MDR Text Key: 95941912
• Report Number: 2024168-2017-10131
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/26/2018

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: 08/09/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70808U214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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): Other