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

Model Number 9582

Device Problems Difficult to Remove (1528); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Used (b)(6) 2018 as the event date since was not provided.Device is a combination product.

Event Description

It was reported via medwatch form 1000060000-2018-8145 that removal difficulty and stent migration were encountered.The target lesion was located in the left main artery.A 4.00x8mm promus premier drug-eluting stent was advanced for treatment during a percutaneous coronary intervention (pci).After the stent was deployed in the target lesion, the balloon were difficult to remove through the unknown guide catheter and so it was removed both at the same time.The balloon and guide catheter were close to the stent in the left main and appeared to have caught on the edge of the balloon catheter and embolized it.The physician attempted to find the stent to snare it, but it was no longer visible on angiography.The patient was monitored for symptoms of neurologic or peripheral vascular complications and nothing was found.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8159837
• MDR Text Key: 130190801
• Report Number: 2134265-2018-63690
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 9582
• Device Catalogue Number: 9582
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 58 YR