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 12/21/2017

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

Event Description

This report is filed as chordal rupture occurred during use of clip delivery system (cds 71006u165).It was reported that this was a mitraclip procedure treating functional mitral regurgitation grade 3.The patient presented with a dilated left ventricle.Two mitraclips were implanted in an intended area and remained stable and well seated, however, the mr remained grade 3.Reportedly, the two implanted mitraclips were performing as intended although there was no reduction in mr.A third clip delivery system (cds 71006u165) was advanced to the mitral valve.After the second grasp of the leaflets, there was a chordal rupture of the anterior medial leaflet.It was decided to not implant this third mitraclip and to remove the device from the anatomy.There was no treatment provided and the mr remained grade 3.There was no additional information provided regarding this issue.

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.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.It should be noted that the reported patient effect of mitral valve injury (tissue damage), as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported failure grasping the leaflets appears to be related to patient morphology/pathology.The reported patient effect of tissue damage appears to be a result of multiple attempts that resulted in failure grasping the leaflet (procedural conditions).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: 7187284
• MDR Text Key: 97139096
• Report Number: 2024168-2018-00336
• 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: 05/07/2018

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: 10/06/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71006U165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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: TWO (2) IMPLANTED MITRACLIPSSTEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 70