MAUDE Adverse Event Report: CPI - DEL CARIBE ACUITY; IMPLANTABLE LEAD

Model Number 4555

Device Problems Human-Device Interface Problem (2949); Positioning Problem (3009)

Patient Problems Atrial Fibrillation (1729); Death (1802); Perforation (2001); Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 11/24/2014

Event Type  Death  

Event Description

Event Description

Boston scientific received information that this patient was presented to the electrophysiology (ep) laboratory in (b)(6) 2014.Following the implant procedure, the patient became hemodynamically unstable and died.The cause of death, as reported by the physician, was attributed to perforation at some point during the placement of the left ventricular (lv) lead.The guiding catheter (acuity pro extended hook, 49 cm) had been inserted into the coronary sinus ostium (cs os) without difficulty.The left ventricular (lv) was inserted but was pulled back due to tracking issues.Following cs contrast injection, contrast could be visualize in the epicardium.Subsequently, the implant procedure proceeded without difficulty.An echocardiogram taken following the procedure identified blood around the heart.A pericardiocentesis was performed and 200 cc of blood was withdrawn.Despite emergency measures, the patient could not be stabilized and died.

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This investigation will be updated should further information be provided.To date, no additional information has been received.

Event Description

Subsequently, boston scientific received the procedural report from the investigation site in early-february 2015.According to the report, a right ventricular (rv) defibrillation lead was implanted without difficulty.A 9.5 french sheath was advanced over the second wire into the axillary vein.An acuity pro sheath was advanced to the right atrium over a long glide wire.During the attempt to cannulate the coronary sinus, the acuity pro sheath perforated the ra wall and entered the pericardial space.This was confirmed with injection of 5 cc of contrast which was noted to fill the pericardial space.The sheath was pulled back and was advanced into the coronary sinus.The patient's blood pressure and heart rate were monitored very closely and remained stable for the duration of the procedure.Coronary sinus cannulation was confirmed with injection of another 5cc of contrast.The lv lead was then advanced over a wire into a lateral branch of the middle cardiac vein, and placed in the low inferolateral aspect of the lv.With adequate threshold, favorable ecg morphology, and no evidence of diaphragmatic stimulation (with high output), it was decided to retain the lead in this location.After the lv lead was secured and the ra lead repositioned due to dislodgement, defibrillation threshold (dft) testing was performed.The patient had stable hemodynamic status post-dft testing.Once the pocket site was dressed, the patient was given cardioversion with 200 joules.This successfully converted the patient's atrial fibrillation to normal sinus rhythm.A limited echo was performed after which did show a moderate sized pericardial effusion, but no evidence of tamponade physiology.As previously reported, at some point following the procedure, a pericardiocentesis was performed and 200 cc of blood was withdrawn.Despite emergency measures, the patient could not be stabilized and died.

Manufacturer Narrative

This follow-up 002 report was not submitted previously.As per request by the fda on january 31, 2024, follow-up 002 has been resubmitted in an effort to release follow-up 003 from hold status.

Event Description

Boston scientific received information that this patient was presented to the electrophysiology (ep) laboratory in (b)(6) 2014.Following the implant procedure, the patient became hemodynamically unstable and died.The cause of death, as reported by the physician, was attributed to perforation at some point during the placement of the left ventricular (lv) lead.

• Brand Name: ACUITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): GUIDANT PUERTO RICO BV; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: timothy degroot vasekar ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 4342793
• MDR Text Key: 5140498
• Report Number: 2124215-2014-21603
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/12/2016
• Device Model Number: 4555
• Other Device ID Number: ACUITY STEERABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided; 02/05/2015
• Supplement Dates FDA Received: 12/18/2014; 02/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• 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: 0293.; 4087.; 4555.; N160.; N160; 0293; 4555; 4087
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Death
• Patient Age: 60 YR
• Patient Sex: Male