MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

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

Patient Problems Fistula (1862); Pain (1994); Thrombosis (2100); Pseudoaneurysm (2605)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is not returning.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This report is filed as a pseudoaneurysm occurred post procedure, requiring treatment.It was reported that on (b)(6) 2018, a mitraclip procedure was performed for mitral regurgitation (mr) greater than or equal to 3+.One mitraclip was implanted, reducing the mr to grade 1+.There was no device malfunction.On (b)(6) 2018, the patient experienced right groin pain.Per duplex sonogram, an aneurysm spurium was diagnosed.Compression was held, a compression bandage was placed, and medication was provided with no improvement.On (b)(6) 2018, surgery was performed as treatment.The event required prolonged hospitalization.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.In this case, there was no reported device malfunction associated with the clip delivery system (cds).The reported patient effects of pain, pseudoaneurysm, fistula, thrombosis and surgery are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported patient effects of pain, pseudoaneurysm, fistula and thrombosis appear to be related to patient morphology/pathology and/or user technique/procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previous medwatch report, the additional information was obtained: on (b)(6) 2018, a mitraclip procedure was performed for severe functional mitral regurgitation with minor signs of degeneration.On (b)(6) 2018, the patient had surgery for an av-fistula and aneurysm spurium.The aneurysm spurium was overstitched and a thromboendarterectomy with end to end anastomosis was performed.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Correction: initial reporter.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8134249
• MDR Text Key: 129372123
• Report Number: 2024168-2018-09327
• 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: health professional,study
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2019

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 Expiration Date: 06/21/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80621U254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 01/24/2019; 01/30/2019
• Supplement Dates FDA Received: 01/31/2019; 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 66