MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0705

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

Patient Problems Perforation (2001); Vascular Dissection (3160)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report an atrial septal defect requiring intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+ with an enlarged atrium.It was noted that after removal of the steerable guide catheter (sgc) a bidirectional shunt was found.The atrial septal defect (asd) was closed with an occluder and the procedure was concluded with a resulting mr of grade 1+.This issue reportedly caused a clinically significant delay, but the delay did not result in adverse patient sequelae.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 the reported event.Based on the information reviewed, a cause for the reported perforation cannot be determined.The reported patient effect of perforation is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

N/a.

Event Description

Subsequent to the previously filed report, additional information was received: immediately post procedure, while returning to the intensive care unit, the patient complained of back pain.A computed tomography (ct) scan was performed and revealed a localized aortic dissection in the descending aorta dorsal to the left atrium.Since the largest short diameter was less than 3 cm, the patient was referred for hypotensive rest medical treatment.It was confirmed that there was no extension of the aneurysm diameter.Two weeks, postoperatively, the patient was independent, walking, and discharged from the hospital.

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 the reported event.Based on the information reviewed, a cause for the reported perforation and vascular dissection could not be determined.The reported patient effect of perforation is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported hospitalization or prolonged hospitalization and unexpected medical intervention were a result of case-specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16135235
• MDR Text Key: 307063381
• Report Number: 2135147-2023-00159
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: SGC0705
• Device Lot Number: 20720R2017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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
• Treatment: 1 MITRACLIP
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Race: Asian