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

Model Number H7493911320300

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) study.It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2013, the patient presented with an unstable angina and was referred for cardiac catheterization and index procedure was performed on the same day.The target lesion #1 was located in the proximal left anterior descending (lad) artery with 85% stenosis, and was 15 mm long with a reference vessel diameter of 4.0 mm.The lesion was treated with 4.00x16mm promus element ¿ drug-eluting stent (des) with 0% residual stenosis.The target lesion #2 was located in the mid lad with 95% stenosis, and was 20 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated by pre- dilatation and placement of 3.00x20mm promus element ¿ des.Following post dilatation, the residual stenosis was 0%.Two days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was diagnosed with an isr in the mid lad and was hospitalized on the same day.After three days, coronary angiography was performed which revealed 80% stenosis in the mid lad.The isr noted was treated with percutaneous coronary intervention (pci) which reduced to 0%.One day post procedure, the outcome of the event was considered to be recovered/ resolved and the patient was discharged on the same day.

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7347034
• MDR Text Key: 102703708
• Report Number: 2134265-2018-02087
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: SIMILAR
• 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: 02/27/2018

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: 05/03/2014
• Device Model Number: H7493911320300
• Device Catalogue Number: 39113-2030
• Device Lot Number: 15752928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2013
• 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: 40 YR