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

Model Number	H7493952838250
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Codes	Dyspnea (1816); Occlusion (1984); Vomiting (2144)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6503081
• Report Number: 2134265-2017-03832
• Device Sequence Number: 18951444
• Product Code: NIQ
• UDI-Device Identifier: 08714729845003
• UDI-Public: (01)08714729845003(17)20170821(10)0018981821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2017

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: 08/21/2017
• Device Model Number: H7493952838250
• Device Catalogue Number: 39528-3825
• Device Lot Number: 0018981821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/19/2017
• 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: Hospitalization; Required Intervention