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

Model Number	H7493952828220
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that a stent dislodged and was surgically removed.The target lesion was a calcified left anterior descending artery.A 2.25 x 28mm promus premier¿ stent was advanced and had difficulty crossing the lesion.A little force was used and then the balloon partially came off the balloon.The stent delivery system and stent were still on the guidewire; the physician intended to pull the entire system with the guidewire into the guide catheter and remove everything from the body.Upon doing this, the stent became further dislodged and embolized.The patient was x-rayed and the stent had migrated to the patient's ankle.The patient was transported to the interventional radiology lab where a vascular surgeon removed the stent.There were no further patient complications and the patient status was stable.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7259162
• Report Number: 2134265-2018-00604
• Device Sequence Number: 1022825
• Product Code: NIQ
• UDI-Device Identifier: 08714729844884
• UDI-Public: 08714729844884
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/17/2018

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: 04/17/2019
• Device Model Number: H7493952828220
• Device Catalogue Number: 39528-2822
• Device Lot Number: 21302850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/09/2018
• 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