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

Model Number	H7493952808350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device code 2923 relates to component code 515.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.But the manufacturing batch record review confirmed that the device met all material, assembly and performance specifications., if the device is returned and , 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 stent dislodgment occurred.The target lesion was located in the very calcified proximal right coronary artery (rca).After pre-dilation was performed, a 3.50x8mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.However, upon removal of the device and when a guidezilla guide extension catheter was inserted, it was noted that the stent had fallen off of the balloon inside the rca.The patient was transferred to another hospital.No further 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: 6553714
• Report Number: 2134265-2017-04497
• Device Sequence Number: 16436707
• Product Code: NIQ
• UDI-Device Identifier: 08714729844624
• UDI-Public: (01)08714729844624(17)20180626(10)20120196
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/18/2017

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: 06/26/2018
• Device Model Number: H7493952808350
• Device Catalogue Number: 39528-0835
• Device Lot Number: 20120196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/09/2017
• 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: Other