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); Incomplete Coaptation (2507)

Patient Problem Mitral Regurgitation (1964)

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 clip remains in the patient.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 that the initial mitraclip procedure was performed on (b)(6) 2018 to treat degenerative mitral regurgitation (mr) with an mr grade of 4.The first clip (71024u143) was implanted successfully in a3/p3.The second clip (71215u181) was advanced, there was difficulty grasping the leaflets in a2/p2, due to very thin leaflets; the leaflets were eventually grasped during the third attempt, reducing the mr to 2.On (b)(6) 2018, transthoracic echocardiogram was performed, which found that the clip (71215u181) in a2/p2 detached from the anterior leaflet and remained attached to the posterior leaflet (slda) and mr increased to 3-4.The patient is stable.No additional treatment is planned for the patient.No additional treatment is planned.

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

Subsequent to the initially filed medwatch report, the following information was received: on (b)(6) 2018, mitral valve replacement was performed.The patient is stable.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: date of event.

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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported single leaflet device attachment(slda) and difficulty grasping appear to be related to patient morphology/pathology.The reported patient effect of mitral regurgitation (mr) is a result of procedural conditions of the slda and difficulty grasping.It should be noted that the reported patient effect of worsening mr 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: 7433438
• MDR Text Key: 105586940
• Report Number: 2024168-2018-02808
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/28/2018

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: 12/16/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71215U181
• 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: 04/27/2018; 06/20/2018; 09/24/2018
• Supplement Dates FDA Received: 05/22/2018; 06/27/2018; 09/28/2018
• 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: ONE ADDITIONAL IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 85 YR