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

Catalog Number SGC0302

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device referenced is being filed under separate medwatch report.

Event Description

This is being filed to report the steerable guide catheter torn tip, difficult to remove, prolonged hospitalization and surgical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted poor lv ejection fraction (25%) with massive mitral regurgitation.On (b)(6) 2019, the first xtr clip was successfully deployed in the medial segment of the a2/p2.A second xtr clip delivery system (cds) was advanced to the mitral valve, and the clip was placed lateral to the first xtr clip.The clip grasped the leaflets fine; however, mr increased, and a leaflet tear was suspected.Therefore, the clip was re-opened to be re-positioned.The clip grasped the leaflets and mr was significantly reduced.Then during clip evaluation, it was observed that the clip jumped opened.Since the clip deployment steps were not yet performed, the grippers were raised, and the clip was unlocked to invert the clip and retract from the left ventricle to the leaflet atrium.But it was not possible to close the clip.It was observed that the clip was detached from the dc shaft, but remained on the gripper line.A lasso catheter was introduced to capture the clip and try to close the clip arms.The clip could not be closed, but the clip was able to be fully inverted.The clip was retracted to the steerable guide catheter (sgc), and both the sgc and clip were retracted to over the septum and back to the groin.Surgery was performed to remove the sgc and the cds with the clip attached.The procedure continued with a new cds and sgc.The clip was deployed to further reduce mr and treat the leaflet tear.Treatment of the leaflet tear was suboptimal.Three clips were implanted, reducing mr to 3-4.Extracorporeal membrane oxygenation (ecmo) was needed to stabilize the patient.On (b)(6) 2019, the patient died due to brain edema, acute respiratory failure, cardiogenic shock, congestive heart failure, and mitral valve insufficiency.The three implanted clips were stable on the leaflets at the time of death.The physician stated that the second clip contributed to the patient death due to the clip caused a delay in the procedure that resulted in blood loss and the patient to become unstable.The returned device analysis identified that the steerable guide catheter (sgc) that was used with the reported clip was returned with a deformed and torn soft tip.No material seem to be missing from the soft tip material.It was confirmed by the physician that the sgc tip became torn when the retracted clip was in the inverted position.Retraction of the sgc was difficult due to anatomical challenges.The sgc was ultimately removed through surgery.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.All available information was investigated and the reported difficulty removing the device could not be replicated in a testing environment.Returned device analysis indicated a torn soft tip.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated and the reported issues appears to be related to procedural conditions due to the clip caught on the soft tip.There is no indication of product issue with respect to manufacture, design or labeling.Correction: remove adverse event.Correction: outcomes attributed to adverse event: change required intervention to na.Correction: type of reportable event: serious injury to a malfunction.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9197008
• MDR Text Key: 163144322
• Report Number: 2024168-2019-12645
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90211U160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 74