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

Catalog Number CDS0502

Device Problems Failure To Adhere Or Bond (1031); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

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 clip entanglement.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips (71109u178, 71120u247) were implanted, reducing mr to 2.The physician decided to place a 3rd (71120u170) clip medial from the first and second clips; however, it was impossible to grasp both leaflets, particularly the posterior mitral leaflet (pml).Several attempts were made without success and the clip became stuck on the anterior mitral leaflet (aml) and chordae.Attempts were made to retract the clip into the left atrium (la) without success.It was decided to deploy the clip onto the aml and chordae.The remaining mr was grade 3+.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).

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 reported event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated, and the reported failure to adhere or bond (difficulty grasping the leaflets) appear to be related to the challenging patient morphology/pathology (barlows disease).The reported entrapment of device or device component (clip caught on chordae) appears to be a combination of patient morphology/pathology and user technique/procedural circumstances (maneuvers related to grasping attempts).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: 7433249
• MDR Text Key: 105687669
• Report Number: 2024168-2018-02805
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 06/22/2018

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: 11/20/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71120U170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 06/14/2018
• Supplement Dates FDA Received: 04/19/2018; 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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
• Patient Outcome(s): Required Intervention