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

Model Number	H7493952812350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the right coronary artery (rca).After a guidewire crossed the lesion, a 3.50 x 12 mm promus premier¿ drug-eluting stent was positioned for deployment.As the physician was deploying the stent in the ostium rca, guide catheter access was lost and the stent was partially deployed at that point.The physician then pulled the guide catheter and the stent delivery system but the stent came off from the delivery catheter.The stent went upstream into the patient and was no longer visible in the rca.The physician advanced another promus stent and successfully deployed the stent which completed the procedure.The patient will undergo neurologic consultation to ensure if further actions will be required by the cardiologist.No further 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: 6400897
• Report Number: 2134265-2017-01925
• Device Sequence Number: 16152787
• Product Code: NIQ
• UDI-Device Identifier: 08714729844686
• UDI-Public: (01)08714729844686(17)20180606(10)0020081603
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2017

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: 06/06/2018
• Device Model Number: H7493952812350
• Device Catalogue Number: 39528-1235
• Device Lot Number: 0020081603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 03/13/2017
• 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
• Patient Age: 65 YR