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

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

Patient Problems Anaphylactic Shock (1703); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Renal Failure (2041); Heart Failure (2206); Respiratory Failure (2484)

Event Date 05/31/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: dates are estimated.The devices were not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot information regarding the complaint devices was not provided.Based on the information provided a conclusive cause for the reported anaphylactic shock, respiratory failure, hemorrhage, recurrent mitral regurgitation, heart failure, and renal failure cannot be determined.The reported patient effect of anaphylactic shock, respiratory failure, hemorrhage, recurrent mitral regurgitation, heart failure, and renal failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.Attachment: article titled, outcomes of urgent/emergent transcatheter mitral valve repair (mitraclip): a single center experience.

Event Description

This is filed to report shock, respiratory failure, bleeding, recurrent mitral regurgitation (mr), heart failure and kidney failure.It was reported through a research article that from january 2018 to march 2019, 20 patient patients underwent urgent/emergent transcatheter mitral valve repair with a mitraclip.Over the 14-month period, the mitraclip may have contributed to shock, respiratory failure, bleeding, recurrent mitral regurgitation (mr), heart failure, kidney failure, hospitalization, medical intervention and surgical intervention.Details are listed in the attached article, titled ¿outcomes of urgent/emergent transcatheter mitral valve repair (mitraclip): a single center experience.¿ no additional information was provided.

• Brand Name: MITRACLIP 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: 10351165
• MDR Text Key: 202073900
• Report Number: 2024168-2020-06367
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/31/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/31/2020
• 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; Disability
• Patient Age: 72 YR