MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

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

Patient Problems Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Heart Failure (2206); Atrial Perforation (2511)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event, test date: dates estimated.(udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.The lot history record for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.Based on the information reviewed, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of hemorrhage, hypertension, myocardial infarction, worsening heart failure and cardiac perforation are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.Attachment titled: iatrogenic atrial septal defect closure after transseptal mitral valve interventions.

Event Description

This is filed to report serious adverse events.It was reported through a research article, that post mitraclip procedure, where patients were re-hospitalized with serious complications.The complications included intracranial hemorrhage, hypertension, myocardial infarction, heart failure, atrial perforation, which required additional treatment.Details are listed in the article titled: iatrogenic atrial septal defect closure after transseptal mitral valve interventions.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• 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: 8686699
• MDR Text Key: 147586498
• Report Number: 2024168-2019-04567
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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
• Date Manufacturer Received: 05/20/2019
• 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; Other; Required Intervention
• Patient Age: 83 YR