MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number UNK SGC01

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

Patient Problems Death (1802); Thrombosis (2100)

Event Date 01/14/2012

Event Type  Death  

Manufacturer Narrative

Date of event: dates are estimated.(udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the available information, a cause for the reported thrombosis and death could not be determined.The reported patient effects of thrombosis and death as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported treatment with medication(s) and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report death and thrombus it was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with an unknown grade.It was noted that the patient was obese and had severe pulmonary disease and chronic renal failure.Two clips were successfully implanted.13 days after the clips were implanted, thrombus was noticed superficial femoral vein in the vascular access site and was treated with medication.However, the patient passed away.Details are listed in the attached article, titled ¿hemodynamic patterns of residual interatrial communication after transcatheter mitraclip repair.¿ no additional information was provided.

Manufacturer Narrative

Nana.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11207962
• MDR Text Key: 227986916
• Report Number: 2024168-2021-00578
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 05/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP; IMPLANTED MITRACLIP
• Patient Outcome(s): Death
• Patient Age: 83 YR