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

Model Number 9386

Device Problem Obstruction of Flow (2423)

Patient Problems Angina (1710); Reocclusion (1985)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study: it was reported that in-stent restenosis and unstable angina occurred.In (b)(6) 2014, the patient was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in proximal left circumflex (lcx) artery with 100% stenosis, a length of 16mm, and a reference vessel diameter of 2.5mm.The target lesion #1 was treated with pre-dilatation and placement of 2.50 x 25 mm promus element stents with the residual stenosis as 0%.Three days after the procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was hospitalized and diagnosed with unstable angina pectoris.The following day, coronary angiography was performed, which revealed 90% stenosis at the proximal lcx.The in-stent restenosis noted in proximal lcx was treated with predilatation and placement of a stent with 0% residual stenosis.Four days later, the event was recovered/resolved, and the patient was discharged.

• Brand Name: PROMUS ELEMENT PLUS
• 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: 8586917
• MDR Text Key: 144291483
• Report Number: 2134265-2019-04900
• 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: 05/07/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2014
• Device Model Number: 9386
• Device Catalogue Number: 9386
• Device Lot Number: 0015990643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2013
• 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: 49 YR