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

Model Number	H7493952828350
Medical Device Problem Codes	Bent (1059); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2017
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 that catheter removal difficulties were encountered and stent damage occurred.The target lesion was located in a coronary artery.After a guide wire crossed the lesion, a 3.50x28mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.The device was removed and a non-bsc guide extension catheter was used.The physician put the stent back through the guide extension catheter but it was still unable to go through.When the physician tried to pull the stent back, the proximal end of the stent got hung up on the mouth of the extension catheter and the physician could not get the stent to re-enter or pull the stent back through the extension catheter.Consequently, the physician had to pull out both devices all at the same time.When the devices were removed, it was noted that there were some struts flared out on the proximal end of the stent that made it caught on the guide extension catheter.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7120807
• Report Number: 2134265-2017-12463
• Device Sequence Number: 1260452
• Product Code: NIQ
• UDI-Device Identifier: 08714729844921
• UDI-Public: 08714729844921
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/22/2017

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: 02/05/2019
• Device Model Number: H7493952828350
• Device Catalogue Number: 39528-2835
• Device Lot Number: 21037973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1