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

Catalog Number SGC0301

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

Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 07/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The mitraclip nt is filed under a separate medwatch report.

Event Description

This is filed to report the full cardiorespiratory arrest that occurred during the procedure.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).The steerable guide catheter was advanced across the interatrial septum when the patient went into cardiorespiratory arrest.Cardiopulmonary resuscitation was performed and the patient was successfully resuscitated.A coronary angiogram was performed, but was unable to identify a cause for the full arrest.The procedure continued and one mitraclip was successfully implanted.When the gripper line was being removed, the clip detached from the posterior leaflet (single leaflet device attachment was noted).A second mitraclip was implanted to stabilize the first clip, reducing mr to grade 1.Attention was then placed on the severe tricuspid regurgitation, but visualization was poor due to the tricuspid anatomy.Leaflet grasping was difficult due to a pacer wire that was adjacent to the septal leaflet.The mitraclip was unable to grasp two tricuspid leaflets simultaneously so the procedure was completed with zero clips on the tricuspid valve.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The reported patient effects of cardiac arrest and respiratory failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 7783452
• MDR Text Key: 117123347
• Report Number: 2024168-2018-06256
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80514U229
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 86