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

Catalog Number SGC0702

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Shock (2072); Tachycardia (2095); Perforation of Vessels (2135)

Event Date 02/24/2022

Event Type  Death  

Event Description

This is filed to report the patient death.It was reported that a mitraclip procedure was performed to treat functional grade 3+ mitral regurgitation (mr).The steerable guide catheter (sgc) was inserted in right femoral vein over the guidewire.Resistance was felt with the femoral vein, the sgc was removed, and the femoral vein was predilated once again followed by sgc insertion under fluoroscopic guidance.When the tip of sgc was placed into left atrium, the patients¿ blood pressure lowered to systolic 65mmhg.No injury was observed.The procedure was continued, one clip was implanted, reducing mr to <1.Blood pressure was stable throughout the rest of procedure around 90-110mmhg with normal heart rhythm.Volume contrast imaging (vci) was injected through the sgc flush port while retracting sgc into femoral vein.Extravasation was noted at the femoral vein/ iliac vein.A 22mmx112mm stent graft was placed and surgical intervention were attempted to treat the vein injury; however, extravasation did not stop.Blood pressure dropped, the heart rhythm increased, massive bleeding was noted which at the end could not be stopped or repaired despite all efforts.The patient went into shock, no treatment was possible resulting in death.Per the physician, it cannot be determined which device caused the injury and patient death, it could be related to a combination of catheter(s)/ wire manipulation(s), sgc insertion, and or pre-existing anatomy.No additional information was provided.

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.

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.A review of lot-specific similar complaints identified no other complaints reported from this lot.Additionally, death, perforation of vessels, shock, hypotension, hemorrhage, and tachycardia are listed in the mitraclip g4 system instructions for use (ifu) as known possible complications associated with mitraclip procedures.Based on available information, the reported difficult steerable guide catheter (sgc) positioning appears to be due to procedural conditions.The reported vein injury appears to be due to procedural conditions (device manipulation/sgc insertion/anatomy).The reported shock, hypotension, hemorrhage, and death appear to be cascading events of the vein injury.A cause for the reported tachycardia could not be determined.Additionally, death, perforation of vessels, shock, hypotension, hemorrhage, and tachycardia are listed in the ifu as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and surgical intervention were the results of case-specific circumstances.This event was further reviewed by an abbott global medical affairs director.The reviewer stated, there is no definitive evidence that death was related to the device, but it was related to the procedure.There is no indication of product issue with respect to manufacture, design or labeling.H6: health effect clinical code 2135 added.H6: removed health effect clinical code 2001.

• Brand Name: G4 STEERABLE GUIDING 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: 13773007
• MDR Text Key: 287240711
• Report Number: 2024168-2022-02670
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 05/04/2022

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: 09/13/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10914R144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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): Death