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

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

Patient Problem Reocclusion (1985)

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

(b)(6) clinical study.It was reported that patient experienced restenosis.In (b)(6) 2018, the patient qualifying condition was myocardial infarction (mi).They were referred for cardiac catheterization and index procedure was performed.The target lesion #1 was located in the proximal right coronary artery (rca) extending up to mid rca with 95% stenosis and was 20mm long, with a reference vessel diameter of 2.25mm.The target lesion #1 was treated with pre-dilatation and placement of a 2.25x24mm promus "priemiere" stent.Following this intervention, post dilatation was performed.The target lesion #2 was located in the distal rca with 95% stenosis and was 16mm long, with a reference vessel diameter of 2.25mm.The target lesion #2 was not treated with pre-dilatation and placement of a 2.25mmx20mm promus priemiere stent.Following this intervention, post dilatation was performed.Sixteen days later, the patient was discharged.In (b)(6) 2018, the patient was noted with restenosis in the right original coronary artery in the primary stent and was hospitalized for further evaluation and treatment.The patient was treated with balloon dilatation.Nineteen days later, the patient was discharged and on the same day, the event was considered to be resolved.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8268755
• MDR Text Key: 133791518
• Report Number: 2134265-2019-00204
• 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: 01/22/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2018
• Initial Date FDA Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 68 YR