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

Model Number 9552

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

Patient Problems Cardiac Arrest (1762); Ischemia (1942); Thrombosis/Thrombus (4440)

Event Date 05/29/2022

Event Type  Death  

Event Description

It was reported that stent thrombosis occurred and the patient died.The 90% stenosed target lesion was located in the non tortuous and moderately calcified mid left anterior descending artery.Ticagrelor was given before the percutaneous coronary intervention and during the procedure heparin was administered.A 28 x 2.50 promus premier drug-eluting stent was deployed.However, after stent deployment, blood pressure was low.After the final injection, the patient was sent to the coronary care unit (ccu).After 30 minutes, the pressure started to fall down again and the patient went into cardiac arrest.The physician deemed a stent thrombosis as there was an ischemia noticed through electrocardiogram (ecg) in that area.The patient was treated with direct-current (dc) shock, then continuous cardiopulmonary resuscitation (cpr) was done but the patient didn't revert.The official cause of death was stent thrombosis.

Event Description

It was reported that stent thrombosis occurred and the patient died.The 90% stenosed target lesion was located in the non tortuous and moderately calcified mid left anterior descending artery.Ticagrelor was given before the percutaneous coronary intervention and during the procedure heparin was administered.A 28 x 2.50 promus premier drug-eluting stent was deployed.However, after stent deployment, blood pressure was low.After the final injection, the patient was sent to the coronary care unit (ccu).After 30 minutes, the pressure started to fall down again and the patient went into cardiac arrest.The physician deemed a stent thrombosis as there was an ischemia noticed through electrocardiogram (ecg) in that area.The patient was treated with direct-current (dc) shock, then continuous cardiopulmonary resuscitation (cpr) was done but the patient didn't revert.The official cause of death was stent thrombosis.It was further reported that the lesion was predilated with a 2.00x12 mm balloon catheter.The stent was fully deployed and post dilatation was not performed.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14784616
• MDR Text Key: 294563594
• Report Number: 2134265-2022-06363
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2023
• Device Model Number: 9552
• Device Catalogue Number: 9552
• Device Lot Number: 0028441476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 07/04/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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
• Patient Outcome(s): Death