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

Catalog Number CDS0502

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Mitral Valve Stenosis (1965); Tissue Damage (2104)

Event Date 02/28/2018

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 clip delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the tissue damage and mitral stenosis.It was reported that the patient, with grade 4 mixed mitral regurgitation (mr) and a mean pressure gradient of 2mmhg, underwent a mitraclip procedure.Two clips were successfully implanted one at the anterior 2/posterior 2 (a2/p2) leaflet segment and the other at the anterior 3/posterior 3 (a3/p3) leaflet segment.The mean pressure gradient increased to 3 mmhg, but mr was reduced to grade 2-3.It was decided to implant a third clip between the two previously implanted clips.Some difficulty was noted grasping the leaflets and a new jet was noted between the two implanted clips.It was felt that the new jet was due to a leaflet perforation.The clip was not implanted and the clip delivery system was removed without issue.An amplatzer plug was placed to seal the leaflet perforation.The procedure ended with mr at grade 1.The mean pressure gradient increased to 7 mmhg.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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of mitral stenosis and mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported failure to adhere or bond could not be determined.The reported mitral valve injury (tissue damage) appears to be related to the reported failure to adhere or bond and patient effect of mitral stenosis was due to procedural circumstances as the mean gradient pressure remained 7mmhg at the end of the procedure.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: 7363588
• MDR Text Key: 103246343
• Report Number: 2024168-2018-02084
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

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: 10/25/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71025U162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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 CATHETERIMPLANTED MITRACLIP (X2)
• Patient Outcome(s): Required Intervention