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 Dyspnea (1816); Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 12/22/2017

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 clip movement and leaflet tear resulting and increased mitral regurgitation (mr).It was reported that the initial mitraclip procedure was performed on (b)(6) 2017, to treat functional mr with a grade of 4.Visualization was difficult due to the dilated heart.One clip was implanted, reducing the mr to 1-2.On (b)(6) 2017, the patient returned with dyspnea and an mr grade of 3-4.Echocardiogram was performed, which found that the posterior leaflet was torn.It appeared that the clip had slightly moved from its initial position on the posterior leaflet.The patient was treated with medication and confirmed to be 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 the reported event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effects of worsening mitral regurgitation (mr), tissue damage and dyspnea as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.All available information was investigated and the reported failure to bond (partial clip movement) appears to be related to both challenging patient morphology/anatomy and procedural circumstances.The reported poor image resolution was related to the dilated heart.The reported mr appears to be a result of partial clip movement and dyspnea was a cascading effect of the mr.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 7232590
• MDR Text Key: 98734878
• Report Number: 2024168-2018-00729
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

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: 07/18/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70629U131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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): Hospitalization; Required Intervention