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

Model Number	H7493952820220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.  (b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported via user/facility medwatch# (b)(4) that stent dislodgement occurred.The target lesion was located in the left anterior descending artery and ramus.A 2.25x20mm promus premier¿ drug-eluting stent was advanced for treatment.However, the device was unable to cross the lesion despite several attempts.Eventually, the stent became dislodged and got stuck inside the guide hub.The devices were removed as a unit and the dislodged stent was recovered from the guide catheter.After the guide catheter was removed from the patient, the distal end of the guide about an inch from the hub was cut and inserted the guide wire in backwards.The dislodged stent popped out at the back end of the guide catheter and the stent was removed.No patient complications were reported.One day post procedure, the patient was discharged.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7203283
• Report Number: 2134265-2018-00232
• Device Sequence Number: 1485939
• Product Code: NIQ
• UDI-Device Identifier: 08714729844761
• UDI-Public: 08714729844761
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2018

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: 01/24/2019
• Device Model Number: H7493952820220
• Device Catalogue Number: 39528-2022
• Device Lot Number: 20969493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR