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

Catalog Number CDS0501

Device Problems Failure To Adhere Or Bond (1031); Incomplete Coaptation (2507)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

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 the single leaflet device attachment (slda).It was reported this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr) with a grade of 4+.The transseptal puncture was difficult due to atrial dilatation; the puncture was low with an aorta hugger.Imaging was challenging due to the anatomy.Standard steering techniques were used to gain height to the mitral valve.The clip delivery system (cds) (70925u343) was advanced to the mitral valve, grasping was difficult due to the annular dilation and due to bi-leaflet prolapse.The leaflets were eventually grasped, and the clip was deployed.However, two minutes later, when removing "m" from the device to remove the delivery system; it was noted that the clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda).The mr was 3+.Since it took approximately 2 hours and 20 minutes to grasp with the clip, the decision was made to discontinue the procedure.The patient remained hospitalized for a second mitraclip procedure, which was performed on (b)(6) 2018.During the second procedure, leaflet grasping was unsuccessful with the cds due to the anatomy.The cds was removed with the clip and the procedure was aborted.The mr remains 3+.The patient is 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 event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the single leaflet device attachment (slda) and failure to adhere/bond (difficult grasping) and poor image resolution in this incident appears to be related to patient morphology/challenging anatomy (bi-leaflet prolapse with annular dilation, coaptation length 0mm, dilated right and left atrium with rotation of the heart).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: 7373477
• MDR Text Key: 103559489
• Report Number: 2024168-2018-02202
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

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: 09/26/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70925U343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 92 YR
• Patient Weight: 95