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

Model Number SGC0701

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Nervous System Injury (2689); Pericardial Effusion (3271)

Event Date 03/23/2021

Event Type  Death  

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.The additional clips referenced are filed under separate medwatch report number(s).

Event Description

This is filed to report pericardial effusion, perforation requiring open heart surgery.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4+ and mean pressure gradient of 6 mmhg.The patient has severe mitral regurgitation (mr) and was turned down by two sites for heart transplant; therefore, it was decided to perform the mitraclip procedure to stabilize the patient for heart transplant.Prior to the procedure, a small pericardial effusion was noted but it was very small and was not addressed.The clip delivery system (cds) (01201u103) was advanced; however, an aorta hugger was noted due to the patient anatomy and there was no support from the septum.Troubleshooting was performed and the cds was positioned.Grasping was performed with difficulty, and the clip got stuck in the chords.The clip was not able to be completely freed and was deployed on the posterior leaflet and chordae.There was no change to mr.It was decided to remove the steerable guide catheter (sgc) (10108u234) and the cds and make a new transseptal puncture that would provide more support.The new transseptal puncture was made in a thicker section of the septum which had more height and support.The same sgc was advanced without issue and the second cds (01201u104) was advanced to the valve.The clip was deployed, reducing mr to 2+.When the sgc was removed, the patient blood pressure dropped and the patient flatlined, cardiopulmonary resuscitation (cpr) was performed.Echocardiogram showed the pericardial effusion had gotten bigger and it was unknown where it was coming from.After 15 minutes of cpr and additional medication, the patient became stable and the patient remained stable for 45 minutes.It was then noted that there was a small hole where the second transseptal puncture had been made.Therefore, the team decided to treat the patient with open heart surgery and stitch the small hole in the septum.The patient was placed on extracorporeal membrane oxygenation (ecmo) and the chest was closed.The patient remains stable, two clips implanted reducing mr to 2+ and mean pressure gradient of 6 mmhg.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 the reported event.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on the available information, the reported difficult or delayed positioning with the anatomy appears to have been related to patient anatomy.The reported perforation appears to have been related to procedural conditions.The reported pericardial effusion, hypotension, and cardiac arrest appear to have been cascading events of the reported perforation.A cause for the reported nervous system injury and death could not be determined.The reported patient effects of perforation, pericardial effusion, hypotension, cardiac arrest, and death, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization or prolonged hospitalization, unexpected medical interventions, required medication, and surgical intervention were results of case-specific circumstances.This event was further reviewed by an abbott medical affairs director ((b)(6)).The reviewer stated that: ¿there is no evidence that death was related to the device but was likely related to the procedure since the need for surgery was prompted by the pericardial effusion." there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report filing, additional information was received reporting that on (b)(6) 2021 the patient died due to no brain activity.The physician suspected that the pericardial effusion became bigger.The clips remained stable and attached to the leaflets.The patient had no brain activity and the family decided to withdraw care and the patient passed away.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
• 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: 11679194
• MDR Text Key: 245811500
• Report Number: 2024168-2021-03209
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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: 01/07/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10108U234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Death; Hospitalization; Required Intervention; Disability
• Patient Age: 7 YR
• Patient Weight: 51