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

Catalog Number SGC0302

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

Patient Problem Atrial Perforation (2511)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.The reported patient effect of atrial perforation as listed in the mitraclip nt system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The investigation was unable to determine a conclusive cause for the atrial perforation.There is no indication of product issue with respect to manufacture, design or labeling.The additional device referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report the atrial septal defect.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.When the steerable guide catheter (sgc) entered the right atrium (ra) to the left atrium (la), the fossa slightly expanded.The clip delivery system (cds) was advanced and steered down to the mitral valve towards p3 and grasping attempted.The clip was moved from the left ventricle (lv) due to poor location when a bright object was noted on echo.After about 30 seconds, the object was not visible.The clip was then deployed on the leaflets, reducing mr to <1.When the steerable guide catheter (sgc) was removed, a right to left shunt was noted.The shunt amount was small therefore no intervention was performed.There was no clinically significant delay in the procedure and no adverse patient sequela.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• 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: 10288903
• MDR Text Key: 201227879
• Report Number: 2024168-2020-05923
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 91127U151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• 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): Other
• Patient Age: 87 YR
• Patient Weight: 46