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

Catalog Number CDS0602-XTR

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Damage (2104)

Event Date 05/07/2018

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 additional relevant information.

Event Description

This is filed to report tissue damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The first clip was implanted without issue.The decision was made to place a second clip on the lateral commissure.During implantation of the clip, on echocardiography during the second grasping attempt, a lesion was observed on the anterior leaflet region a2/a1.The grasping issue was due to tension on the anterior leaflet.It was no longer possible to grasp the leaflet for a good reduction of mr.The decision was made to abort the procedure; therefore, the clip was removed undeployed.The final mr was confirmed to be 3.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: brand name, catalog number.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 this event.Additionally, a review of the complaint history identified no similar incident 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.All available information was investigated and a definitive cause for the reported failure to adhere or bond (leaflet grasping - clip not implanted) could not be determined in this incident.Additionally, the reported tissue damage appears to be due to user technique/procedural conditions.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 XTR 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: 7561927
• MDR Text Key: 109834232
• Report Number: 2024168-2018-04066
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/24/2018

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: 01/19/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80118U113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 07/24/2018
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 81 YR