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

Catalog Number UNK CDS

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Renal Failure (2041); Transient Ischemic Attack (2109); Heart Failure (2206); Cardiogenic Shock (2262); Atrial Perforation (2511)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date - estimated.The devices were not returned for analysis.A review of the lot history records and similar complaint reviews could not be performed as the part and lot information regarding the complaint devices were not provided.The reported patient effects of heart failure, atrial perforation, atrial fibrillation, hypertension, renal failure, cardiogenic shock, cerebrovascular accident, and transient ischemic attack as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the available information, a cause for the reported patient effects of heart failure, atrial perforation, atrial fibrillation, hypertension, renal failure, cardiogenic shock, cerebrovascular accident, and transient ischemic attack could not be determined.The reported hospitalization and additional therapy/non-surgical treatment were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The patient deaths mentioned in b5 and in the article are filed under separate mfr report numbers.Literature title : risk of percutaneous iatrogenic atrial septal defect closure required shortly after transseptal mitral valve intervention.

Event Description

This will be filed to report the serious injuries.It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, heart failure, atrial perforation, atrial fibrillation, hypertension, renal failure, cardiogenic shock, stroke, ischemic attack, re-hospitalization, and medical intervention.Details are listed in the attached article, titled ¿risk of percutaneous iatrogenic atrial septal defect closure required shortly after transseptal mitral valve intervention.¿ please see article for additional information.

• 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: 11182385
• MDR Text Key: 227736759
• Report Number: 2024168-2021-00499
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2021

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: 01/07/2021
• Initial Date FDA Received: 01/15/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 81 YR