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

Device Problem Obstruction of Flow (2423)

Patient Problems Angina (1710); Myocardial Infarction (1969); Reocclusion (1985); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 02/01/2015

Event Type  Injury  

Manufacturer Narrative

Dr.Junsuke shibuya, et.Al., "a case of unstable angina and st-elevated myocardial infarction associated with late stent thrombosis within the different stents after pci", the 27th congress of japanese association of cardiovascular interventional and therapeutics: medical general oral presentation mo390, 2018-08-04, 9:00-10:00, 4f 402.Event date was not reported and approximated 02/01/2015.Implant date as not reported and approximated as 10/01/2014.Device is combination product.(b)(4).

Event Description

It was reported via journal article that in stent restenosis, angina, st segment elevation, thrombosis and myocardial infarction occurred.In october 2014, the patient was hospitalized for acute myocardial infarction and a non bsc drug coated stent was implanted in the left anterior descending (lad) artery and a promus premier drug coated stent implanted in the distal left circumflex(lcx) coronary artery.In february 2015, the patient was again hospitalized for unstable angina associated with stent restenosis of the lad as well as the lcx which were treated with the use of drug coated balloon (dcb) dilation.The patients medication was changed from clopidogrel to prasugrel.In november 2016, the patient was again diagnosed with stable angina associated with stent restenosis of the lad which was treated with a non-bsc stent.In june and november 2017, the patient was again hospitalized with st elevation myocardial infarction related to stent thrombosis.Both times the reoccurring stent thrombosis was treated with dcb and aspiration thrombectomy.We experienced a case of repeated late stent thrombosis in different stents after pci.

• Brand Name: PROMUS PREMIER
• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8550219
• MDR Text Key: 143082231
• Report Number: 2134265-2019-04366
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/25/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR