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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Edema (1820); Mitral Regurgitation (1964)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date estimated.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is conservatively filed to report the increased mitral regurgitation (mr).It was reported that the initial mitraclip procedure was performed on an unknown date to treat mixed mitral regurgitation (mr).On (b)(6) 2018, a second mitraclip procedure was performed.One clip was implanted, reducing the mr from 4 to 2-3.No additional information was provided.

Manufacturer Narrative

(b)(4).Corrections: female added, date of event corrected, lot number changed to unk, implant date corrected.(b)(4).The device was not returned for analysis.A review of the lot history record for both lot numbers identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated the reported partial clip movement appears to be related to the challenging patient pathology/morphology (short and thin posterior mitral leaflet/pml).The reported mitral regurgitation (mr) was likely due to the clip being partially attached/detached from pml, and the dyspnea and edema the cascading effects of mr.The reported patient effects of worsening mr, dyspnea and edema as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially report filed, the following information was received: the initial mitraclip procedure was performed on (b)(6) 2018.Two clips were implanted, reducing the mr from 3-4 to 1-2.On (b)(6) 2018, the patient was re-hospitalized with shortness of breath and leg edema.Diuretic medication was given to treat the shortness of breath and leg edema.On (b)(6) 2018, echocardiogram was performed, which found that one implanted clip was attached to the anterior leaflet and partially attached to the posterior.On (b)(6) 2018, a second mitraclip procedure was performed.One clip was implanted, reducing the mr from 4 to 2-3.No additional information was provided.

• 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: 7402957
• MDR Text Key: 104570388
• Report Number: 2024168-2018-02526
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDS0502
• Device Lot Number: 70905U125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention