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

Model Number 9551

Device Problem Obstruction of Flow (2423)

Patient Problems Angina (1710); Reocclusion (1985)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

(b)(6) clinical study.It was reported unstable angina (stent stenosis) occurred.In (b)(6) 2018, the subject was referred for cardiac catheterization and index procedure was performed.The target lesion was located in the proximal left anterior descending (lad) artery extending up to mid lad with 95% stenosis and was 45mm long, with a reference vessel diameter of 3.5mm.The target lesion was treated with pre-dilatation and placement of two study stents (3.00 x 24mm and 3.50 x 24mm).Following post-dilatation, the residual stenosis was 0%.Six days later, the subject was discharged on aspirin and other anti platelet medication.In (b)(6) 2019, the subject was diagnosed with unstable angina (stent stenosis) and was hospitalized for further evaluation on the same day.The event was not treated medically.Three days later, the event was considered resolved and the subject was discharged.

• 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: 9336435
• MDR Text Key: 166839539
• Report Number: 2134265-2019-13974
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2020
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0021893234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• 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: 62 YR