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 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The mitraclip xtr is currently not commercially available in the us; however, it is similar to a device sold in the us.The other mitraclip device referenced, is filed under a separate medwatch report.

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 3-4.While establishing final arm angle with the first xtr clip, the clip opened.It was then noted that the lock lever was no longer fully advanced against the handle.The leaflets were re-captured and the clip was closed and deployed, this time holding in the lock lever through the rest of the steps.The second xtr clip was positioned adjacent to the first clip, on the medial side of the clip.After closing the clip the gradient was assessed to be around 7mmhg, so the clip was repositioned.A gradient and mr reduction were noted, so the clip was deployed.Afterward, the results were not as expected.It could not be determined whether the posterior leaflet was torn or had not been adequately captured by the second clip.Final mr grade was 2 and the patient remained 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 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 (ifu), is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported failure to adhere or bond (leaflet capture) appears to be related to procedural conditions as the transseptal puncture was higher than intended.Additionally, a definitive cause for the suspected tissue damage could not be determined.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: 7442067
• MDR Text Key: 105873844
• Report Number: 2024168-2018-02901
• 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: 06/21/2018

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: 01/10/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80110U159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 06/21/2018
• 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): Other