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

Model Number 9554

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 05/26/2021

Event Type  Injury  

Event Description

(b)(6) registry. It was reported that angina and restenosis occurred. In (b)(6) 2019, the subject was referred for cardiac catheterization and 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 mid rca with 85% stenosis and was 64 mm long, with a reference vessel diameter of 3. 5 mm. The lesion was treated with pre-dilatation and placement of a 3. 50 mm x 38 mm and a 3. 50 mm x 32 mm promus premier stent systems. Following this, post-dilatation was performed with residual stenosis as 10%. Seven days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and was hospitalized on the same day for further evaluation and treatment. On the following day, the subject was referred for coronary angiography which revealed 60% stenosis in mid rca which had previously placed study device was treated with percutaneous coronary balloon dilatation (tvr) and percutaneous coronary intervention (pci). Post intervention, residual stenosis was 10%. The rationale of intervention was angina. Two days later, the event was recovered and resolved and, on the same day, the subject was discharged 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: 12471401
• MDR Text Key: 271472797
• Report Number: 2134265-2021-11024
• 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: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/13/2020
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0022544421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2018
• 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: 09/14/2021 Patient Sequence Number: 1