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

Model Number SGC0301

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

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100); Foreign Body In Patient (2687)

Event Date 09/24/2020

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.The mitraclip referenced is filed under a separate medwatch report number.

Event Description

This is filed to report pulmonary embolism and foreign body.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Prior to the procedure, it was noted that the patient had a flail of the mitral valve.After the steerable guide catheter (sgc) was inserted, a blood clot was observed at the tip of the dilator.The sgc was removed and aspiration was performed to remove the blood clot.It was noted that a portion of the blood clot was removed, but the other portion of the blood clot had migrated into the lungs.The blood clot then became lodged in the auricle appendage.The sgc and clip were then inserted and both leaflets were successfully grasped; therefore, the clip was attempted to be implanted.While removing the lock line, the lock line became stuck and was unable to be removed.At this time, it was noted that a knot had occurred on the lock line.In an attempt to retrieve the lock line, the physician tried breaking the lock lever; however, this was unsuccessful.The physician then decided to pull on the lock line until it broke.The physician stated that roughly 8 to 10 inches remained in the anatomy.It was noted that the clip was stable on the leaflets, but as a precaution, the physician decided to implant an additional clip to make sure the clip was completely stable.Mr reduced to a grade of <1.For treatment of the blood clot, the patient was put on blood thinners.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the reported thrombus cannot be determined.The reported foreign body in patient appears to be related to procedural circumstances.The patient effects of thrombus and foreign body in patient are listed in the instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.Patient code removed; patient code added.

• 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: 10793209
• MDR Text Key: 214820073
• Report Number: 2024168-2020-09254
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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: 12/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00213U159
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DILATOR; DILATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 79