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

Model Number N/A

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

Patient Problems Perforation (2001); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/01/2018

Event Type  Death  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of event: dates estimated.The udi number is not known as the part and lot number were not provided.The additional patient effects reported in the article are captured under a separate medwatch report.Article titled, ¿iatrogenic atrial septal defect requiring transcatheter closure following transcatheter mitral valve repair.¿.

Event Description

This is filed to report a perforation left untreated, heart failure requiring intervention and patient death.It was reported that a patient with left ventricular (lv) dysfunction underwent a mitraclip procedure to treat severe functional mitral regurgitation (fmr).After the mitraclip procedure the patient had an iatrogenic atrial septal defect (iasd) and developed right sided heart failure due to right ventricular volume overload with left-to-right shunt, leading to low cardiac output syndrome.Transcatheter closure of the iasd could not be performed at the hospital due to the unmet of the institutional requirements.Therefore, the patient¿s heart failure was treated with an intra-aortic balloon pump (iabp).Six weeks post procedure the patient died due to the right sided heart failure.No additional information was provided.

Manufacturer Narrative

The products were not returned for analysis.The lot history record (lhr) review and similar complaint review were not performed because this incident was based on a review article, and no device/lot information was provided.Based on the limited information provided, the reported death appears to be related to heart failure.The reported heart failure and atrial perforation were caused by the iatrogenic atrial septal defect (iasd) associated to procedural circumstances.Additionally, death, heart failure, and atrial perforation are listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

N/a.

• 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: 14269231
• MDR Text Key: 290642966
• Report Number: 2024168-2022-04718
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

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 Model Number: N/A
• Device Catalogue Number: UNK SGC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 05/03/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/28/2022
• 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): Death
• Patient Age: 86 YR
• Patient Sex: Male