MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC CARDIA PROMUS ELITE 3.00X 20MM / STENT; CORONARY DRUG-ELUTING STENT

Lot Number 25234974

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/08/2020

Event Type  malfunction  

Event Description

In process of fixing the right coronary artery, the stent was not able to be advanced in the coronary artery and it was decided to retract the stent.In the process of retracting the stent, the stent was dislodged at the level of the radial artery.Vascular surgeon was consulted and stent was left alone on the wall as it was stuck and not moving.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC CARDIA PROMUS ELITE 3.00X 20MM / STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10142821
• MDR Text Key: 195002358
• Report Number: MW5094940
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 25234974
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 91