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

Model Number 9554

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

Patient Problem Atherosclerosis (1728)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: the 2nd affiliated hospital of (b)(6).Device is combination product.

Event Description

(b)(6) study.It was reported that coronary atherosclerotic cardiopathy occurred.In (b)(6) 2018, the subject presented with unstable angina and was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the proximal right coronary artery (rca) extending up to the distal rca with 99% stenosis and was 96 mm long, with a reference vessel diameter of 2.75 mm.The lesion was treated with pre-dilatation and placement of three study stents (2.50 x 38 mm, 2.75 x 38 mm and 2.75 x 38 mm).Following post-dilatation, the residual stenosis was 0%.The subject was discharged four days later on aspirin and clopidogrel.In (b)(6) 2019, 385 days post index procedure, the subject was diagnosed with coronary atherosclerotic cardiopathy and was hospitalized for further evaluation on the same day.It was noted the event was not treated medically.Four days later, the event was considered resolved with residual effects and the subject was discharged home on the same day.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9298791
• MDR Text Key: 166049113
• Report Number: 2134265-2019-13604
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0021543231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2017
• 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): Required Intervention
• Patient Age: 43 YR