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

Catalog Number CDS0501

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Damage (2104)

Event Date 04/18/2018

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 suspected tissue damage.It was reported that this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr) with a grade of 4.The first clip was advanced to the mitral valve and the leaflets were grasped.However, as leaflet insertion was being evaluated, it was noted that the posterior leaflet slipped off the cilp arm.Attempts to re-grasp the leaflets was difficult due to the anatomy, the clip was repositioned medially and the leaflets were grasped.The clip was implanted; however, a leaflet tear was suspected and the mr returned to 4.A second clip was implanted to further reduce the mr.The mr remained significant, thus a 16mm amplatzer device was placed between the two clips; reducing mr to 1-2+.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 this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the reported failure to adhere or bond (difficulty grasping the leaflets and leaflet capture) was related to the challenging patient anatomy/morphology (restricted posterior leaflet).The reported tissue damage appears to be a cascading effect of the difficulty grasping the leaflets.It should be noted that the reported patient effect of mitral valve injury (tissue damage) is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.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: 7499441
• MDR Text Key: 107769768
• Report Number: 2024168-2018-03411
• 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: 06/27/2018

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: 12/07/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71207U193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 107