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

Model Number 9554

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Fibrillation (1729)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that atrial fibrillation occurred.In (b)(6) 2019, the subject was diagnosed with stable angina and index procedure was performed.Target lesion #1 was located in the mid left anterior descending (lad) with 80% stenosis and was 38 mm long, with a reference vessel diameter of 2.75 mm.The lesion was then treated with a promus premier stent.The target lesion #2 was located in the proximal lad with 80% stenosis and was 24 mm long, with a reference vessel diameter of 3.5 mm.The target lesion #2 was treated with pre-dilatation and placement of a 3.50 mm x 20mm promus premier stent.Following this intervention, post dilatation was performed.Post procedural stenosis was reported as 0% for proximal lad.The subject was discharged with medication.In (b)(6) 2019, the subject was noted with atrial fibrillation and was hospitalized on the same day.Atrial septal puncture, three dimensional cardiac mapping and radiofrequency ablation were performed in response to this event.Six days later, the event was considered resolved and the subject was discharged on the same day.

Manufacturer Narrative

Device is a combination product.Correction made in "describe event or problem": it was further reported that target lesion #2 was located in the mid lad to proximal lad with 80% stenosis and was 38mm long, with a reference vessel diameter of 2.75 mm.The target lesion #2 was treated with pre-dilatation and placement of a 2.75 mm x 38 mm promus priemiere stents.Post procedural stenosis was reported as 0% for proximal lad to mid lad.The subject was discharged four days post index procedure.Previously reported as "the target lesion #2 was treated with pre-dilatation and placement of a 3.50 mm x 20mm promus premier stent.Following this intervention, post dilatation was performed.Post procedural stenosis was reported as 0% for proximal lad.The subject was discharged with medication." updates: model/catalog number updated from unknown to 9554.Device lot # updated from unknown to 0023064076.Unique identifier (udi) # updated from unknown to (b)(4).Device manufacture date updated from unknown to 11/30/2018.

Event Description

Promus premier china clinical study.It was reported that atrial fibrillation occurred.In (b)(6) 2019, the subject was diagnosed with stable angina and index procedure was performed.Target lesion #1 was located in the mid left anterior descending (lad) with 80% stenosis and was 38 mm long, with a reference vessel diameter of 2.75 mm.The lesion was then treated with a promus premier stent.The target lesion #2 was located in the proximal lad with 80% stenosis and was 24 mm long, with a reference vessel diameter of 3.5 mm.It was further reported that target lesion #2 was located in the mid lad to proximal lad with 80% stenosis and was 38mm long, with a reference vessel diameter of 2.75 mm.The target lesion #2 was treated with pre-dilatation and placement of a 2.75 mm x 38 mm promus priemiere stents.Post procedural stenosis was reported as 0% for proximal lad to mid lad.The subject was discharged four days post index procedure.Previously reported as "the target lesion #2 was treated with pre-dilatation and placement of a 3.50 mm x 20mm promus premier stent.Following this intervention, post dilatation was performed.Post procedural stenosis was reported as 0% for proximal lad.The subject was discharged with medication." in (b)(6) 2019, the subject was noted with atrial fibrillation and was hospitalized on the same day.Atrial septal puncture, three dimensional cardiac mapping and radiofrequency ablation were performed in response to this event.Six days later, the event was considered resolved and the subject was discharged on the same day.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8838176
• MDR Text Key: 152544161
• Report Number: 2134265-2019-08403
• 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
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0023064076
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR