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

Model Number H7493952828220

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2017

Event Type  Injury  

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 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¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7259162
• MDR Text Key: 99595562
• Report Number: 2134265-2018-00604
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844884
• UDI-Public: 08714729844884
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention