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

Model Number H7493918438270

Device Problem Occlusion Within Device (1423)

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

Event Date 02/12/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that stent thrombosis occurred and the patient died.Vascular access was obtained via the femoral artery.The 90% stenosed target lesion with a bend of between 45 and 90 degrees was located in the moderately tortuous and moderately calcified right coronary artery.A 2.75 x 38 mm promus element¿ plus drug-eluting stent was implanted to treat the lesion.However, post procedure, the patient's blood pressure dropped.Subsequently, repeat angiography was performed which revealed a severe stent thrombosis.Another stent was then implanted in response to the event; however, 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: 7393533
• MDR Text Key: 104213073
• Report Number: 2134265-2018-02655
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2018
• Device Model Number: H7493918438270
• Device Catalogue Number: 39184-3827
• Device Lot Number: 19844929
• 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: 04/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2016
• 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: 60 YR