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 Problem Perforation (2001)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated date.The udi and part number are not known as the lot number was not provided.The device is not returning for analysis.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attached article, titled "qca to guide treatment of inter-clip mitral regurgitation between two previously implanted mitraclips.".

Event Description

This is filed to report atrial perforation.It was reported through literature review of the article titled, qca to guide treatment of inter-clip mitral regurgitation between two previously implanted mitraclips, that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.It was noted hypertension, hyperlipidemia, hypothyroidism, mitral valve disease, and frailty presented with symptoms of progressively worsening dyspnea on exertion.On an unknown date, two nt clips were successfully implanted, reducing mr to 1.Then approximately two years and 6 months later, the patient experienced recurrent mr.The clips were both stable on the leaflets.The physician stated the cause of the recurrent mr is due to disease of progression.The patient underwent a second mitraclip procedure to treat the recurrent mr.A steerable guide catheter (sgc) was advanced to the mitral valve, and an nt clip was deployed, reducing mr.The sgc was removed; however, a left to right shunt was observed.The atrial perforation was left without closure.One clip was implanted, reducing mr to 1.The patient was discharged the next day.One month follow-up revealed significant improvement, and mr is remains mild.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review, and device/lot information was not provided.Based on available information, a cause for the perforation could not be determined.Furthermore, perforation is listed in the instructions for use as a known possible complication associated with mitraclip procedures.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: 12078841
• MDR Text Key: 263570401
• Report Number: 2024168-2021-05481
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• 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
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 IMPLANTED MITRACLIP
• Patient Outcome(s): Other
• Patient Age: 79 YR