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

Catalog Number UNK SGC03

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

Patient Problem Atrial Perforation (2511)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

Event date: estimated date.The udi is unknown because the part number and lot number were not provided.(b)(4).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.A cause for the reported patient effect of atrial perforation could not be determined.The reported patient effect of atrial perforation is listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment and hospitalization were results of case-specific circumstances.It should also be noted that the mitraclip ifu states: ¿do not use mitraclip outside of the labeled indication¿.Since mitraclip was used for a tricuspid valve procedure, this is considered as an off-label use of the device.However, it could not be determined if using the mitraclip on the tricuspid valve caused or contributed to the reported patient effects.There is no indication of a product quality issue with respect to manufacture, design or labeling.Article titled, " comparison of transcatheter tricuspid valverepair using the mitraclip ntr and xtr systems".The additional mitraclip referenced is filed under a separate medwatch report number.

Event Description

This is filed to report atrial perforation, medical intervention, heart failure, and prolonged hospitalization.It was reported in an article review that this was a mitraclip procedure to treat tricuspid regurgitation (tr).A steerable guide catheter (sgc) was advanced to the tricuspid valve, with an xtr clip delivery system (cds) for off label use.The clip was deployed.A 30-day follow-up revealed that the patient was re-admitted 18 days post clip-implantation for heart failure.Additionally, imaging showed evidence of an atrial perforation which was treated with a closure device.No additional information was provided.

• 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: 11132705
• MDR Text Key: 225573711
• Report Number: 2024168-2021-00219
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention