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

Model Number 9548

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Date 09/01/2020

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the heavily calcified and previously stented left anterior descending artery/diagonal vessel.Predilatation was performed with drug-eluting balloon catheter.The patient experienced some discomfort during inflation but was otherwise was okay.A 12 x 2.25 promus premier drug-eluting stent was advanced for treatment.However, the device failed to deliver and it came off the balloon upon removal.Subsequently, the undeployed stent was crushed with another stent in the left main.Patient was admitted for 48 hours for observation and was discharged after.

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the heavily calcified and previously stented left anterior descending artery/diagonal vessel.Predilatation was performed with drug-eluting balloon catheter.The patient experienced some discomfort during inflation but was otherwise was okay.A 12 x 2.25 promus premier drug-eluting stent was advanced for treatment.However, the device failed to deliver and it came off the balloon upon removal.Subsequently, the undeployed stent was crushed with another stent in the left main.Patient was admitted for 48 hours for observation and was discharged after.It was further reported that the lesion had 95% stenosis with moderate bend.Resistance was encountered during advancing in the highly calcified lesion and passed through previously implanted stents.The device held pressure when attempting to deploy and no leaks were noted.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10520461
• MDR Text Key: 206491382
• Report Number: 2134265-2020-12617
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0024823929
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention