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

Catalog Number SGC0705

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Ischemia (1942); Perforation (2001)

Event Date 03/31/2021

Event Type  Death  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report tissue damage, hypotension, hemorrhage, medical intervention, surgical intervention, delay and prolonged hospitalization.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.It was noted prolapsed posterior.The steerable guide catheter (sgc) was advanced to the mitral valve; however, the patient¿s blood pressure dropped.Medication was administered to raise the blood pressure.After the clip grasped the leaflets, the blood pressure dropped again.It was noted there was tension in the lower abdomen and suspected bleeding.The clip was deployed and mr was sufficiently reduced.However, the blood pressure did not stabilize after clip placement.Therefore, a blood transfusion was performed.After the blood pressure stabilized, angiography and computed tomography revealed a torn vein at the right femoral and iliac vein.The oxygen saturation was not good and the patient experienced acute respiratory distress syndrome (ards).Then the blood pressure dropped again and the patient continued to tension in the lower abdomen.This caused a clinically significant delay in the procedure as the patient was sent to surgery for additional treatment.One clip was implanted, reducing mr to 2.On 04/2/2021, the vein was surgically treated but the patient did not recover and died.No additional information was provided.

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 that would have contributed to this event.Based on the available information, a cause for the reported hypotension could not be determined.The perforation appears to be due to procedural conditions.The hemorrhage, non-cerebral ischemia, death and hypoxia appear to be cascading effects of the perforation.The reported medication, delay to treatment, unexpected medical intervention, surgical intervention, and hospitalization were the result of case-specific circumstances.Additionally, hypotension, hemorrhage, death, hypoxia, perforation, and non-cerebral ischemia are listed in the instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the initially filed report, the following additional information was received: the vein was surgically treated on (b)(6) 2021, and not on (b)(6) 2021.The cause of death was bowel ischemia that was attributed to the perforation of the right iliac vein.The physician stated the sgc is possibly related to the patient death due to the vein possibly perforated during sgc insertion or the vein was turned with sgc during advancement.No additional information was provided.

• 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: 11688559
• MDR Text Key: 246118490
• Report Number: 2024168-2021-03267
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 01112U110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; STEERABLE GUIDE CATHETER; CLIP DELIVERY SYSTEM; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Weight: 34