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 Hypoxia (1918); Perforation (2001)

Event Date 11/27/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated date.Udi #: the udi number is not known as the part and lot number were not provided.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the atrial septal defect (asd) and treatment.It was reported via literature that this was a mitraclip procedure to treat functional mitral regurgitation (mr).The mitraclip was successfully implanted.Hours after the procedure, the patient experienced severe right-to-left shunting with a subsequent decline in oxygen saturation in merely hours after the procedure, which resolved after percutaneous iatrogenic atrial septal defect (iasd) closure.No additional information was provided.Details are listed in the attached article: "haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy.

Manufacturer Narrative

D4: the udi# is unknown because the part and lot numbers were not provided.The device was not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.The reported patient effects of perforation (cardiac) and hypoxia (respiratory distress) as listed in the mitraclip system instructions for use (ifu) are known possible complication associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported perforation could not be determined in this complaint.The reported hypoxia was a cascading effect of the perforation.The reported unexpected medical intervention appears to be due to case specific circumstance as the patient perforation was treated with a closure.Although a conclusive cause for the reported patient effect and the relationship to the device, if any, cannot be determined, there is no indication of a product 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: 11724903
• MDR Text Key: 247285779
• Report Number: 2024168-2021-03515
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR