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

Model Number 9554

Device Problem Obstruction of Flow (2423)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 02/28/2021

Event Type  Injury  

Event Description

Promus premier (b)(4) registry: it was reported that unstable angina and restenosis occurred. In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catherization. The index procedure was performed on the same day. The target lesion 1 was located in the proximal right coronary artery (rca) extending up to distal rca with 95 % stenosis and was 38 mm long, with a reference vessel diameter of 3. 5 mm. The target lesion 1 was treated with pre-dilatation and placement of 3. 50 mm x 38 mm promus premier stent system. Following this post-dilatation was performed with 0% residual stenosis. Additionally, an additional drug eluting stent was implanted during the index procedure. Three days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2021, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment. Medication was given to treat the event. On the following day, the subject was referred for coronary angiography which revealed 50% stenosis in proximal rca which had previously placed study device was treated with percutaneous coronary intervention (pci) / target vessel revascularization (tvr). Post intervention, residual stenosis was 0%. It was noted that the rationale of intervention was angina. Two days later, the event was recovered/resolved and the subject was discharged on the same day on aspirin and clopidogrel.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14116195
• MDR Text Key: 289423282
• Report Number: 2134265-2022-04144
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/18/2020
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0022855947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/14/2022 Patient Sequence Number: 1