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

Model Number 9386

Device Problem Obstruction of Flow (2423)

Patient Problem Reocclusion (1985)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

Evolve china clinical study- it was reported that in-stent restenosis occurred.In (b)(6) 2014, the patient presented with unstable angina as well as other objective evidence of ischemia and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion #1 was located in the mid left anterior descending artery with 80% stenosis and was 15mm long with a reference vessel diameter of 3.5mm.The lesion was treated with pre-dilatation and placement of a 3.5mmx 20mm study stent, resulting in 0% stenosis.Two days post procedure, the patient was discharged on acetylsalicylic acid and clopidogrel.In (b)(6) 2019, the patient was noted with an in-stent restenosis and was hospitalized on the same day.The patient underwent percutaneous coronary intervention and blood transfusion was also carried out to treat the event.The event was considered to be recovered/resolved the same day.

Event Description

Evolve china clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2014, the patient presented with unstable angina as well as other objective evidence of ischemia and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion #1 was located in the mid left anterior descending artery with 80% stenosis and was 15mm long with a reference vessel diameter of 3.5mm.The lesion was treated with pre-dilatation and placement of a 3.5mmx 20mm study stent, resulting in 0% stenosis.Two days post procedure, the patient was discharged on acetylsalicylic acid and clopidogrel.In (b)(6) 2019, the patient was noted with an in-stent restenosis and was hospitalized on the same day.The patient underwent percutaneous coronary intervention and blood transfusion was also carried out to treat the event.The event was considered to be recovered/resolved the same day.It was further reported in (b)(6) 2019, coronary angiography revealed the in-stent restenosis was located in the proximal part of lad with 80% stenosis.Post intervention, the residual stenosis was 0%.At the time of reporting the patient was still hospitalized.

Manufacturer Narrative

Device is a combination product.

Event Description

Evolve china clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2014, the patient presented with unstable angina as well as other objective evidence of ischemia and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion #1 was located in the mid left anterior descending artery with 80% stenosis and was 15mm long with a reference vessel diameter of 3.5mm.The lesion was treated with pre-dilatation and placement of a 3.5mmx 20mm study stent, resulting in 0% stenosis.Two days post procedure, the patient was discharged on acetylsalicylic acid and clopidogrel.In (b)(6) 2019, the patient was noted with an in-stent restenosis and was hospitalized on the same day.The patient underwent percutaneous coronary intervention and blood transfusion was also carried out to treat the event.The event was considered to be recovered/resolved the same day.It was further reported in (b)(6) 2019, coronary angiography revealed the in-stent restenosis was located in the proximal part of lad with 80% stenosis.Post intervention, the residual stenosis was 0%.At the time of reporting the patient was still hospitalized.It was further reported in (b)(6) 2019, two days after intervention was completed, the event was considered recovered/resolved and the patient was discharged the same day.

Manufacturer Narrative

Device is a combination product.

• Brand Name: PROMUS ELEMENT PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8575477
• MDR Text Key: 143889326
• Report Number: 2134265-2019-04788
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2014
• Device Model Number: 9386
• Device Catalogue Number: 9386
• Device Lot Number: 0016108453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR