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

Model Number	9582
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was a restenosis of a previously implanted non-bsc stent in the calcified proximal circumflex artery one month ago.There was a chunk of calcium proximal to the stent.After pre-dilatation was performed with a 2.5x15mm nc emerge balloon catheter at 20 atmospheres, a 2.50x8mm promus premier was advanced but failed to cross the lesion.The physician decided to pull the device out; however, after multiples attempts to get the device out, the physician felt a pop.Upon inspection, it was noted that the stent came off the balloon and was stuck in the calcium proximal to the lesion.A 2.5x12mm emerge balloon catheter was then advanced and used to deploy the stent in a normal fashion with excellent results.No patient complications nor blood loss were reported.The device was not returned.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is adverse event related to patient condition.

• Brand Name: PROMUS PREMIER
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7944909
• Report Number: 2134265-2018-61708
• Device Sequence Number: 13869316
• Product Code: NIQ
• UDI-Device Identifier: 08714729844594
• UDI-Public: 08714729844594
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: 9582
• Device Catalogue Number: 9582
• Device Lot Number: 0021610486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention