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

Model Number H7493952838250

Device Problem Bent (1059)

Patient Problems Dyspnea (1816); Occlusion (1984); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

It was reported that the patient experienced dyspnea, and stent damage and occlusion occurred.In (b)(6) 2016, a 2.50x38mm promus premier¿ drug-eluting was implanted for treatment.However, in 2017, the patient started to have difficulties in breathing.The patient contacted the hospital where the procedure was performed but did not receive any call back.Three or four weeks later, the hospital called the patient back and scheduled the patient for a stress test.In the meantime, the patient sought second opinion from a physician from another hospital.Over the following week, the patient's condition worsened to the point of having difficulties getting out of bed in the morning, having no energy, and difficulties in breathing persisted.The patient felt ill, was scared, and was throwing up.In (b)(6) 2017, the patient underwent a nuclear stress test and it was noted that the previously implanted stent was completely smashed and there was all kinds of blockage.The patient was admitted to the second hospital and underwent a heart catheterization.The physician used a balloon catheter to open up the previously implanted stent and the patient started to breath pretty well.The procedure was completed with no further patient complications reported.

• 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: 6503081
• MDR Text Key: 73115669
• Report Number: 2134265-2017-03832
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729845003
• UDI-Public: (01)08714729845003(17)20170821(10)0018981821
• 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2017
• Device Model Number: H7493952838250
• Device Catalogue Number: 39528-3825
• Device Lot Number: 0018981821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention