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

Model Number 9315

Device Problem Obstruction of Flow (2423)

Patient Problems Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study. It was reported that stent thrombosis and st segment elevation myocardial infarction (stemi) 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 was located in the proximal left anterior descending artery (lad) with 80% stenosis and was 38mm long with a reference vessel diameter of 4. 00mm. The lesion was treated with direct placement of a 4. 00x38mm promus element long drug-eluting stent. Following post dilatation, the residual stenosis was 3%. An additional 2. 5x33mm non-bsc stent was implanted to treat the lesion. Three days after the procedure, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2017, 833 days post index procedure, the patient was diagnosed with stent thrombosis lead to acute stemi and on the same day, the patient was hospitalized for further evaluation. In (b)(6) 2017, 841 days post index procedure, the patient was referred for coronary angiograph which revealed stent thrombosis from the proximal lad (which had previously placed study device) to mid lad which was treated with percutaneous coronary intervention to mid lad. Following intervention, % residual stenosis was unknown. On the next day, the event was considered to be recovered/ resolved and the patient was discharged.

• Brand Name: PROMUS ELEMENT LONG
• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8760374
• MDR Text Key: 150018048
• Report Number: 2134265-2019-07607
• 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

• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/21/2015
• Device Model Number: 9315
• Device Catalogue Number: 9315
• Device Lot Number: 0017008295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/03/2019 Patient Sequence Number: 1