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 05/20/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of event: date estimated.

Event Description

It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Three clips were implanted, reducing mr to 2+.After the mitraclip procedure an atrial septal defect (asd) closure device was implanted to treat a post iatrogenic atrial septal defect.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because no device/lot information was provided.Based on available information, a cause for the reported perforation could not be determined.However, the reported patient effects of perforation is listed in the instruction for use (ifu), is known possible complications 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.B3: date of event corrected.

• 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: 12268668
• MDR Text Key: 264789515
• Report Number: 2024168-2021-06760
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

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: 07/19/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 IMPLANTED MITRACLIPS; 3 IMPLANTED MITRACLIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR