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

Model Number 9315

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

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Device is combination product.

Event Description

(b)(6) clinical study.It was reported that primary hypertension occured.In (b)(6) 2014, the subject under went an index procedure on the 99% stenosed target lesion, located in the proximal left anterior descending artery (lad), a length of 35 mm, and a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 38 mm promus element stent.Following post dilatation, the residual stenosis was 0%.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2018,1455 days post index procedure, the subject presented with primary hypertension and was subsequently hospitalized for further treatment.It was noted medication was given to treat this event.Ten days later, the patient was discharged.It was noted the event was considered to be recovering/resolving.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8950113
• MDR Text Key: 156143598
• Report Number: 2134265-2019-10395
• 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: 08/30/2019

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: 03/29/2015
• Device Model Number: 9315
• Device Catalogue Number: 9315
• Device Lot Number: 0016503022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR