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

Model Number H7493918416300

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Thrombosis (2100)

Event Date 02/19/2018

Event Type  Death  

Manufacturer Narrative

Device is combination product.Device evaluated by mfr: the complaint device was not received for analysis.The investigation conclusion was unable to be determined.(b)(4).

Event Description

It was reported that the patient died.At an unknown time after a promus element plus stent was implanted, the patient died.Cause of death is unknown.

Manufacturer Narrative

Patient identifier, date of birth, patient sex, event date, describe event or problem, upn- search, upn, catalog/model #, device lot number, device expiration date, patient codes, device codes, device manufactured date: updated.(b)(4).

Event Description

It was further reported this is the same case as mdr#2134265-2018-03629.Immediately following a proper stent implantation, after the procedure acute in-stent thrombosis occurred.There had been adequate pharmacological therapy with dual antiplatelet agents and weight-adapted heparin.Despite immediate re-coronary angiography, the patient died.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the 90% calcified right coronary artery was pre-dilated twice.12 atmospheres for 16 seconds and 12 atmospheres for 9 seconds.After, the 3.5 x 20mm promus element plus was implanted in the proximal portion of the lesion at 14 atmospheres for 18 seconds, and a 3.0 x 16mm promus element plus was implanted in the distal portion at 15 atmospheres for 16 seconds.The result was noted to be good after implantation.Ten minutes later, the patient felt pain in their chest and became hemodynamically unstable.Resuscitation was administered for 30 minutes without success.An angiogram showed that there was a thrombotic occlusion in the proximal right coronary artery.

• 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: 7464018
• MDR Text Key: 106588879
• Report Number: 2134265-2018-03628
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• 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,Followup,Followup
• Report Date: 09/10/2018

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: 09/25/2019
• Device Model Number: H7493918416300
• Device Catalogue Number: 39184-1630
• Device Lot Number: 21197216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 05/17/2018; 09/10/2018
• Supplement Dates FDA Received: 06/11/2018; 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2017
• 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: 70 YR