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

Catalog Number SGC0702

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

Patient Problems Perforation (2001); Cardiogenic Shock (2262)

Event Date 08/11/2021

Event Type  Death  

Manufacturer Narrative

The device was discarded and will not be returning.A follow-up report will be submitted with all additional relevant information.

Event Description

Patient id: (b)(6).This is filed for atrial septal defect, requiring closure and cardiogenic shock, resulting in death.It was reported that this was a mitraclip procedure, performed on (b)(6) 2021, treating functional mitral regurgitation (mr) of grade 3.Two clips were implanted and the mr was reduced to grade 1+.One day post procedure, an atrial septal defect (asd) occluder was placed to close the hemodynamically relevant asd.The asd resolved on (b)(6) 2021.On (b)(6) 2021, the patient experienced cardiogenic shock, related to the asd, and a non-abbott ventricular assist device was placed for mechanical circulatory support.However, the patient died on (b)(6) 2021, of causes related to cardiogenic shock.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of atrial septal defect (asd), cardiogenic shock, and death are listed in the mitraclip g4 system instructions for use (ifu) as known possible complications associated with mitraclip procedures.Based on available information, the asd appears to be due to procedural conditions.The cardiogenic shock appears to be a cascading event of the asd.The death appears to be a cascading event of the cardiogenic shock.The reported hospitalization, use of a asd occluder, and ventricular assist device (vad) are the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12460637
• MDR Text Key: 271050484
• Report Number: 2024168-2021-08112
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10206U414
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIPS (X2), IMPELLA; IMPLANTED MITRACLIPS (X2), IMPELLA
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 41