MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 STEERABLE GUIDE CATHETER; CATHETER, STEERABLE

Model Number SGC0701

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

Patient Problems Respiratory Distress (2045); Atrial Perforation (2511)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.In this case, there was no reported device malfunction associated with the steerable guide catheter (sgc).The reported patient effects of atrial perforation and respiratory distress as listed in the are known possible complications associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product issue with respect to manufacture, design or labeling.The mitraclip referenced is filed under a separate medwatch report number.

Event Description

Patient id: (b)(6).This report is filed due to a clinically significant atrial septal defect.It was reported that on (b)(6) 2020, the patient presented with degenerative mitral regurgitation (mr) grade 4+, a posterior leaflet prolapse and flail.Two mitraclips (cds0701-xtw, 91021u117 and 91021u121) were implanted without a device issue, reducing the mr to grade 1+-2+.On (b)(6) 2020, at the time of discharge the patient became hypoxic on exertion.Prolonged hospitalization was required.On (b)(6) 2020, per imaging, the mr had increased to grade 4+.The clips had remained stable, however, secondary chordae of the p2 leaflets, attached to the most lateral clip, had ruptured.Reportedly, it is unknown which implanted clip had the associated ruptured chordae.A residual bidirectional iatrogenic atrial shunt was also observed.As treatment, another mitraclip was implanted, reducing the mr to mild, and an atrial septal defect (asd) occluder was placed.The event resolved without sequela.No additional information was provided regarding this issue.

• Brand Name: MITRACLIP G4 STEERABLE GUIDE CATHETER
• 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: 9783106
• MDR Text Key: 183497949
• Report Number: 2024168-2020-01980
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2020

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: 06/03/2020
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 91204U156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 82