MAUDE Adverse Event Report: ABBOTT VASCULAR SGC07; CATHETER, STEERABLE

Model Number SGC0701

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

Patient Problems Atrial Perforation (2511); Test Result (2695)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation and there was no device malfunction reported.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, the reported atrial perforation resulting in an abnormal test result appears to be related to procedural circumstances.The reported patient effects of atrial septal defect (atrial perforation), abnormal test results as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional two devices referenced are filed under separate medwatch report numbers.There was no issue with the second and third implanted mitraclip ntw.Na.

Event Description

This is filed on the steerable guide catheter to report the atrial septal defect resulting in oxygen desaturation.It was reported that this was a mitraclip procedure in the patient with p2/3 flail and grade 4 degenerative mitral regurgitation (mr).The first mitraclip ntw was advanced and the grippers were checked, but only one of the grippers was responding to the gripper lever.This first ntw was removed from the patient, undeployed.Another mitraclip ntw was inserted and had difficulty grasping.Although the leaflet was not in the apex of the mitraclip, it was thought that there was enough leaflet insertion that all the gripper fixation elements were on leaflet tissue by way of measuring leaflet pre and post clip closure.The physician thought this should be stable enough to place another lateral clip to ensure a durable result.After deployment, the clip shifted and lost some of the posterior leaflet, but remained on both mitral valve leaflets.A second mitraclip, an nt, was implanted medial to the ntw clip, but it did not stabilize the first clip.A third mitraclip, another nt, was implanted lateral to the first mitraclip.Mr was reduced to grade 1-2.Right to left flow was noted and the oxygen saturation dropped into the low 80s.An atrial septal occluder was implanted which stopped the flow reversal (right to left) and subsequently, the oxygen saturation improved and returned to 100%.The procedure continued with the implantation of two mitraclip ntws on the tricuspid valve reducing tricuspid regurgitation to grade 1.No additional information was provided.

• Brand Name: SGC07
• Type of Device: CATHETER, STEERABLE
• 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: 9888434
• MDR Text Key: 186559220
• Report Number: 2024168-2020-03011
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190167
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2020
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00106U102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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