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

Catalog Number UNK SGC03

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

Patient Problems Respiratory Distress (2045); Atrial Perforation (2511)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature article title ¿iatrogenic atrial septal defect after percutaneous mitral valve repair with mitraclip:should we consider closing them routinely¿.

Event Description

This is filed to report respiratory distress and atrial perforation.It was reported through a research article that a patient underwent a mitraclip procedure to treat functional mitral regurgitation (mr) with an unknown grade.One clip was successfully implanted, successfully reducing mr.However, after the clip was implanted, echocardiography showed an abrupt oxygen desaturation.A right to left shunt was then observed.To treat the shunt, an 12mm closure device was implanted.After the closure device was implanted, the patient showed immediate hemodynamic improved.Details are listed in the article, titled ¿iatrogenic atrial septal defect after percutaneous mitral valve repair with mitraclip: should we consider closing them routinely?" no additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record could not be performed as the lot information regarding the complaint device was not provided.Based on the available information, a cause for the reported atrial perforation and respiratory distress could not be determined.The reported patient effect of atrial perforation and respiratory distress are listed in the mitraclip system instructions for use and are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 10928740
• MDR Text Key: 218988997
• Report Number: 2024168-2020-10038
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

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
• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP; IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR