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

Model Number	H7493952832350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Age at time of event: 18 years or older.Device evaluated by mfr: 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 patient chest discomfort and shortness of breathing issues occurred.A patient with a previously implanted 3.50 x 32 mm promus premier¿ stent in the mid left anterior descending artery and a non bsc pacemaker underwent magnetic resonance imaging (mri) scans of the right and left knee.The pacemaker was set to 70 beats per minute and in mr mode.During the first scan of the right knee, hospital staff positioned the oxygen saturation probe on the patient's left hand and placed the left hand over the patient's chest in the vicinity of the heart and pacemaker and the patient experienced significant chest discomfort and breathing issues.The attending staff noted that during the scans, episodes of oxygen saturation (spo2) loss occurred.During the second mri scan of the left knee the spo2 probe was located at the left side of the patient.The patient did not experience any chest discomfort or breathing issues and there was no loss of oxygen saturation.The patient impact was transient and patient recovered when stimulus was removed.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7619411
• Report Number: 2134265-2018-05453
• Device Sequence Number: 1623691
• Product Code: NIQ
• UDI-Device Identifier: 08714729844983
• UDI-Public: 08714729844983
• 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: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2019
• Device Model Number: H7493952832350
• Device Catalogue Number: 39528-3235
• Device Lot Number: 0021045460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC ADVISA A2DR01 PACEMAKER
• Outcome Attributed to Adverse Event: Other