MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problem Death (1802)

Event Date 07/07/2015

Event Type  Death  

Manufacturer Narrative

Death, event, implant dates estimated.The devices were not returned for analysis and a review of the lot history record and the similar complaint review could not be performed as the part and lot information regarding the complaint devices were not provided.Additionally, a cause for the patient effect of death could not be determined; however, death is listed in the instructions for use (ifu) as potential complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.Literature attachment.Article title long-term survival after mitraclip1 therapy in patients with severe mitral regurgitation and severe congestive heart failure: a comparison among survivals predicted by heart failure models.

Event Description

This is filed to report patient death.It was reported through a research article identifying the mitraclip device which maybe be related to patient death.Details are listed in the attached article, titled long-term survival after mitraclip therapy in patients with severe mitral regurgitation and severe congestive heart failure: a comparison among survivals predicted by heart failure models.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11422014
• MDR Text Key: 234948843
• Report Number: 2024168-2021-01736
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2021

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: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/05/2021
• 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): Death