MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3825

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

Patient Problems Angina (1710); Reocclusion (1985)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) registry.It was reported that angina occurred.On (b)(6) 2020, the subject presented for index procedure.Heparin or anti-thrombin was administered.The 90% stenosed, 3.5 x 15mm target lesion was located in the left main coronary artery (lmca) extending to proximal left anterior descending (lad) artery.Timi flow was 3.The target lesion was pre-dilated with a 4.0 mm x 15 mm balloon, followed by treatment with a 4.0 mm x 20 mm agent dcb balloon with residual stenosis of 20% and timi flow of 3.The subject was discharged on aspirin and ticagrelor.On (b)(6) 2020, the subject presented with unknown symptoms and was hospitalized.Diagnosis revealed aggravation of stable angina.The next day, a cutting balloon was used to treat the 90% stenosis noted in the proximal lad target lesion resulting in 20% residual stenosis and timi flow 3.No other action was taken and the patient was discharged.On (b)(6) 2020, the event was considered resolved without sequelae.

• Brand Name: AGENT
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10606315
• MDR Text Key: 209162728
• Report Number: 2134265-2020-13390
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 09/30/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2020
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 0908H18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR