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

Model Number	9584
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the tortuous and calcified right coronary artery.A 3.00 x 16mm promus premier drug-eluting stent was selected for use.However, when placing the stent, the physician "felt a catch" and so, the device was removed from the patient's body.There were no visible damaged noted upon inspection.The physician then advanced the stent back through the guide catheter but could not see the stent on the balloon.The device was inflated at 3 atmopheres and was confirmed that the stent was not on the balloon.Flouroscopy was used to examine the guide catheter and found out that the stent had fallen off from the balloon during insertion.The device was removed outside the guide catheter.The procedure was completed with a different device.No patient complications were reported.

• 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: 8469324
• Report Number: 2134265-2019-03253
• Device Sequence Number: 11264176
• Product Code: NIQ
• UDI-Device Identifier: 08714729844730
• UDI-Public: 08714729844730
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2020
• Device Model Number: 9584
• Device Catalogue Number: 9584
• Device Lot Number: 0022693184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR