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

Catalog Number SGC0302

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The device was not returned.The reported patient effect of hemorrhage as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.It should be noted that the intended use section of the mitraclip system, ifu states: ¿the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation¿ since, the device was used for a tricuspid valve procedure, this is considered as an off-label use of the device.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, the reported patient effect of hemorrhage appears to be due to procedural condition.Although a conclusive cause for the reported patient effect of hemorrhage 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.The 3rd clip is being filed under a separate medwatch report number.

Event Description

This is being filed to report after removal of the steerable guide catheter, bleeding occurred at the access site requiring medical intervention.It was reported that this was a mitraclip procedure to treat a tricuspid regurgitation (tr) with grade of 4+.One clip was implanted successfully.A second clip delivery system (cds) was advanced to the mitral valve and the clip was placed, but when gripper line removability was checked, the gripper line did not move.Therefore, it was decided to remove the cds and use a new cds.However, it was impossible to safely remove the clip from the anterior septal leaflet as there was tension noted with chordae and the leaflets.And to avoid any tissue damage of the leaflets and chordae, it was decided to deploy the clip and finalize the procedure.The gripper line was left in place and cut at the groin of the patient.Three clips implanted reducing tr to 3+.After removal of the steerable guide catheter (sgc), bleeding complication was noted at the groin.A small artery was bleeding of a smaller side branch artery.Bleeding was not due to the gripper line inability to be removed.It was reported that during vascular access this artery must have been punctured simultaneously at gaining access to femoral vein.The sgc must have damaged this artery or side branch during withdrawal from the patient anatomy and surgical suture was used for treatment.There was no device issue with the sgc or dilator.There was no evidence of tissue damage during the procedure.Patient was hemodynamically stable with no abnormalities noted at the groin during the procedure.No additional information was provided.

• Brand Name: 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: 9482544
• MDR Text Key: 175223820
• Report Number: 2024168-2019-14629
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2019

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: 07/29/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90730U224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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
• Patient Outcome(s): Required Intervention