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

Model Number H7493918428270

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100)

Event Date 02/10/2018

Event Type  Death  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-02647.It was reported that the stent thrombosis occurred and patient died.Vascular access was obtained via the femoral artery.The 90% stenosed with a >45 degree bend target lesion was located in the moderately tortuous and moderately calcified proximal to distal left anterior descending artery(lad).A 3.50x20mm and 2.75x28mm promus element¿ plus stent were implanted.However, patient's blood pressure dropped and patient's angiography revealed severe stent thrombosis in the proximal lad.The physician tried to implant another stent and after some time, the patient expired.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 7396912
• MDR Text Key: 104360506
• Report Number: 2134265-2018-02648
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NP
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2018

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: 08/16/2019
• Device Model Number: H7493918428270
• Device Catalogue Number: 39184-2827
• Device Lot Number: 0021044034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2018
• Initial Date FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2017
• 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): Death
• Patient Age: 61 MO