MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS06

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Flutter (1730); Dyspnea (1816); Tachycardia (2095)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: dates estimated.The clip remains in patient.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 filed to report tachycardia and atrial flutter treated by catheter ablation which is considered medical intervention it was reported through a research article identifying a case study in which a (b)(6) year-old man who underwent a mustard operation in 1972 followed by a second cardiac intervention in 1996 for pulmonary venous baffle enlargement had mitraclip procedure to treat tricuspid regurgitation (tr) with grade 3.The patient was considered high-risk for surgical intervention.Thus, off-label percutaneous repair using the mitraclip was recommended for potential bridge to transplantation.One xtr clip was implanted, reducing tr to 2.The patient was discharged day 2 after the procedure and came back at 7 days with dyspnea and tachycardia associated with atrial flutter.The patient underwent a computerized tomography (ct) to exclude a thrombus in the systemic atrium, which also confirmed the position of the clip.The patient was treated by catheter ablation and discharged on the next day in sinus rhythm on rivaroxaban and his home heart failure medications.Clinical and echographic assessment at 1- and 6-month showed major clinical improvement.Details are listed in the attached article, titled edge to edge repair using a mitraclip for severe tricuspid valve regurgitation after a mustard operation.No additional information was provided.

Manufacturer Narrative

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.Based on the information reviewed, a conclusive cause for the reported atrial flutter, dyspnea and tachycardia could not be determined in this complaint.The reported patient effects of atrial flutter, dyspnea and tachycardia as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The unexpected medical intervention were a result of case-specific circumstance as documented within this article.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 XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11761698
• MDR Text Key: 248591543
• Report Number: 2024168-2021-03713
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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 CDS06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR