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

Model Number	H7493952816300
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: 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 withdrawal difficulties and stent dislodgement occurred.The target lesion was located in the distal left main artery.A 3.00x16mm promus premier¿ drug-eluting stent was advanced to treat the lesion.During delivery of the device, the front edge of the stent became trapped within ostial left anterior descending calcification and the device was unable to be advanced or retracted.The physician attempted to pull the device back further; however, the stent stripped off of the delivery balloon.A stent with smaller balloon was tried and the procedure was completed.Further medical intervention was required.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6556583
• Report Number: 2134265-2017-04534
• Device Sequence Number: 95305
• Product Code: NIQ
• UDI-Device Identifier: 08714729844730
• UDI-Public: (01)08714729844730(17)20180425(10)19921176
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/19/2017

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: 04/25/2018
• Device Model Number: H7493952816300
• Device Catalogue Number: 39528-1630
• Device Lot Number: 19921176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/10/2017
• 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: Required Intervention
• Patient Age: 70 YR