MAUDE Adverse Event Report: BOSTON SCIENTIFIC AMPLATZ SUPERSTIFF GUIDEWIRE 2), SWANZ-GANZ CATHETER; WIRE, GUIDE, CATHETER

Device Problems Obstruction of Flow (2423); Patient-Device Incompatibility (2682)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Ventilator Dependent (2395); Lethargy (2560); Heart Block (4444); Respiratory Insufficiency (4462)

Event Type  Injury  

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, as the amplatz ss.035 260cm wire crossed the stenotic aortic valve, complete heart block occurred.Temporary pacing and medications were initiated.Patient continued to be hypotensive after treatment of the heart block, and was treated with vasopressors.Several hours post-implant, ventricular tachycardia was noted, for which cardiopulmonary resuscitation (cpr) was initiated for 30 minutes.The patient spontaneously converted into sinus rhythm, and medications were initiated.One day post-implant, after weaning from the ventilator, the patient was hypercarbic, requiring intubation and ventilator support.It was also determined that the temporary pacing catheter may have been irritating the myocardium, inducing the arrythmia.The decision was made to remove the pacing swan catheter.There were no further episodes of ventricular tachycardia.Two days post-implant, creatinine increased from pre-implant 1.17 to 1.73.Medication was prescribed, and the issue resolved 6 days post-implant.Four days post-implant, problems with the swan ganz 7.5 vip with paceport temporary pacemaker capture and persistent symptomatic heart block necessitated a permanent pacemaker implant, resolving the heart block.Numerous attempts to wean the patient from the ventilator or extubate were unsuccessful.One and a half weeks post-implant a tracheostomy was performed.Numerous bronchoscopy procedures were required for removal of mucous plugs which were causing exacerbation of respiratory insufficiency.The patient was started on antibiotics for pneumonia.Additional information was received that one month post implant the patient was resuscitated from pea arrest.Neurological exam immediately upon return of pulses revealed left facial droop and obtunded.Stroke team consulted and ct head and neck with contrast performed.Nihss 23 at time of neurologic exam.Facial droop resolved within a few minutes and was awakened several hours later.Ct was negative for stroke.Neurologist attributed symptoms to hypo perfusion in the setting of right mid-cerebral artery stenosis.No treatment was given and the condition resolved the same day.No additional adverse patient effects have been reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AMPLATZ SUPERSTIFF GUIDEWIRE 2), SWANZ-GANZ CATHETER
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17525065
• MDR Text Key: 321142742
• Report Number: MW5132007
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: LDF.