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

Model Number	9588
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: (b)(6).Device is a combination product.
Event or Problem Description
It was reported that stent dislodgment occurred and removal difficulties were encountered.A 2.25x32 mm promus premier stent was advanced for treatment.However, the stent embolized from the obtuse marginal in the duel ostium left system.Upon removal of the entire system, the stent inadvertently snagged the over-hang of a 3.5 promus premier stent in the left main artery.The physician attempted to remove the devices but both stents could not be pulled into the sheath and remained in the femoral artery.A contralateral approach was performed with a non-bsc self-expanding stent that was placed to cover both stents in the femoral artery.The section was post-dilated and the procedure was completed.No further patient complications were reported.

• Brand Name: PROMUS PREMIER
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7851291
• Report Number: 2134265-2018-60727
• Device Sequence Number: 1703805
• Product Code: NIQ
• UDI-Device Identifier: 08714729844945
• UDI-Public: 08714729844945
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: 09/10/2019
• Device Model Number: 9588
• Device Catalogue Number: 9588
• Device Lot Number: 0021892190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/06/2018
• 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