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

Model Number H7493952808300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Chest Tightness/Pressure (2463)

Event Date 05/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as mdr id #: 2134265-2015-08077, 2134265-2015-08075 and 2134265-2015-08074.(b)(6).It was reported that myocardial infarction (mi) occurred.In (b)(6) 2015, index procedure was performed.Target lesion #1 was a de novo lesion located in the mid right coronary artery (rca) with 80% stenosis and was 20 mm long with a reference vessel diameter of 2.75mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00x24mm promus premier everolimus-eluting platinum chromium coronary stent.Visual estimate was with 0% residual stenosis.Target lesion #2 was a de novo lesion located in the proximal rca with 90% stenosis and was 10mm long with a reference vessel diameter of 3.00mm.Target lesion #2 was treated with pre-dilatation and placement of a 3.00x32mm promus premier everolimus-eluting platinum chromium coronary stent.Visual estimate was with 0% residual stenosis.Target lesion #3 was located in the proximal rca with 70% stenosis and was 20mm long with a reference vessel diameter of 3.00mm.Target lesion #3 was treated with pre-dilatation and placement of a 3.00x32mm promus premier everolimus-eluting platinum chromium coronary stent.Post-dilatation was performed with 15% residual stenosis.Target lesion #4 was a de novo lesion located in the mid lad with 70% stenosis and was 25mm long with a reference vessel diameter of 3.75 mm.Target lesion #4 was treated with pre-dilatation and placement of a 2.75x28mm promus premier everolimus-eluting platinum chromium coronary stent.Visual estimate was with 0% residual stenosis.One day post index procedure, the patient experienced the event of elevated cardiac enzymes which was categorized as a myocardial infarction and prolonged the patient's hospitalization.The patient experienced chest tightness while walking to the restroom and was thought to possibly be related to a side branch compromise.Signs and symptoms were relieved by lan.The patient was started on lose-dose amlodipine.On the next day, the event was considered resolved and the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2015, the signs and symptoms experienced by the patient were relieved by long-acting nitrates(lan).Specifically, the patient received isosorbide dinitrate.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5258908
• MDR Text Key: 32450418
• Report Number: 2134265-2015-08078
• Device Sequence Number: 1
• Product Code: NIQ
• 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,Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: H7493952808300
• Device Catalogue Number: 39528-0830
• Device Lot Number: 17618192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2015
• 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
• Patient Age: 51 YR