MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

Model Number 9549

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

Patient Problems Perforation of Vessels (2135); Cardiogenic Shock (2262); Pericardial Effusion (3271); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  Death  

Manufacturer Narrative

E1 initial reporter address: (b)(6).

Event Description

It was reported that a perforation and pericardial effusion occurred and the patient died.The patient presented with the left main (lm) to left anterior descending (lad) arteries and left circumflex (lcx) artery diffusely and severely diseased.Poor left ventricular function was also noted.The distal lm to lad lesion was 70% stenosed and highly calcified.The ostial lcx lesion was 80% stenosed.Severely calcified and tortuous.The lad was stented with a 2.75 mm x 38 mm promus premier and 3.50 mm x 24 mm promus premier.A 2.75 mm x 16 mm promus premier was deployed in the lcx.Intravascular ultrasound was performed using an opticross catheter.During post-dilation in the lad, a perforation and pericardial effusion occurred.The physician inflated a balloon at the site of the pericardial effusion in an attempt to arrest the flow, but was unsuccessful.The physician decided that coronary artery bypass surgery (cabg) was necessary.Before the cabg procedure, the patient became hemodynamically unstable and expired.The official cause of death was cardiogenic shock.

Manufacturer Narrative

E1 initial reporter address: (b)(6).

Event Description

It was reported that a perforation and pericardial effusion occurred and the patient died.The patient presented with the left main (lm) to left anterior descending (lad) arteries and left circumflex (lcx) artery diffusely and severely diseased.Poor left ventricular function was also noted.The distal lm to lad lesion was 70% stenosed and highly calcified.The ostial lcx lesion was 80% stenosed.Severely calcified and tortuous.The lad was stented with a 2.75 mm x 38 mm promus premier and 3.50 mm x 24 mm promus premier.A 2.75 mm x 16 mm promus premier was deployed in the lcx.Intravascular ultrasound was performed using an opticross catheter.During post-dilation in the lad, a perforation and pericardial effusion occurred.The physician inflated a balloon at the site of the pericardial effusion in an attempt to arrest the flow, but was unsuccessful.The physician decided that coronary artery bypass surgery (cabg) was necessary.Before the cabg procedure, the patient became hemodynamically unstable and expired.The official cause of death was cardiogenic shock.Upon further review by a medical professional, it was determined that the 2.75 mm x 16 mm promus premier deployed in the lcx and opticross catheter could not have caused or contributed to the lad perforation, pericardial effusion and subsequent death.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18257940
• MDR Text Key: 329621487
• Report Number: 2124215-2023-67744
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9549
• Device Catalogue Number: 9549
• Device Lot Number: 0030734260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: Asian