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

Model Number H7493952808400

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

During a percutaneous coronary intervention (pci), doctor deployed a 4.0 x 8mm promus premier stent in the left main artery.He was unable to remove the balloon through the guide, so he removed the balloon and guide together.When he imaged the left main again, the stent was no longer visible.The stent was not visible on the balloon or in the guide that had been removed.It appeared that the balloon caught on the edge of the stent, embolizing it when the balloon and guide was removed.He was unable to find the stent.After deploying the stent in the left main, doctor was unable to pull the balloon catheter back through the guide catheter.As a result, he removed both at the same time.This is acceptable practice in this situation.Since the guide and balloon catheter were close to the stent in the left main, the stent appeared to have caught on the edge of the balloon catheter and embolized.He attempted to find the stent, but it did not show up on angiography, so he was unable to attempt to snare it.The patient was monitored for symptoms of neurologic or peripheral vascular complications and nothing was found.It was a coronary stent.The stent was a promus premier drug eluting stent, size 4.0x8 mm.It is made by boston scientific.(b)(4) and the manufacturer catalog # is 395280840.I do not have the lot number because the package was not saved.No harm to patient.Device is not available for return.

• Brand Name: PROMUS PREMIER
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8068785
• MDR Text Key: 127124412
• Report Number: 8068785
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H7493952808400
• Device Catalogue Number: H7493952808400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA