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 Problem Restenosis (4576)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

(b)(6) registry.It was reported that restenosis occurred.In (b)(6) 2020, the subject presented for the index procedure with stable angina.The first target lesion was located in the distal left anterior descending artery (lad) with 70% stenosis, 30 mm long with a reference vessel diameter of 2.75mm.The target lesion was treated with predilatation, using a 2.75mm x 30mm agent (dcb) balloon and had a 10% residual stenosis.Post dilatation was not performed.The second target lesion was located in the left main coronary artery (lmca) extending to the proximal lad with 80% stenosis, 42mm long with a reference vessel diameter of 3.5mm.The target lesion was treated with predilatation, using a 3.50mm x 30mm and a 3.50 x 12mm agent dcb and had a 10% residual stenosis.Post dilatation was not performed.The subject was discharged the next day on aspirin and clopidogrel.In (b)(6) 2020, post index procedure, the subject developed restenosis in the distal lad and lm restenosis.The event resulted in hospitalization and target vessel revascularization (tvr) was performed.On the same day, the subject was referred for coronary angiography which revealed 70% stenosis in the left main coronary artery (lmca).Revascularization was recommended.The stenosis noted in the lmca was treated with a percutaneous coronary intervention with a drug eluting stent with a 20% residual stenosis.The rationale of intervention was due to an angiographic finding without symptoms or objective signs of ischemia.The event was considered to be recovered and 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: 11293234
• MDR Text Key: 230712577
• Report Number: 2134265-2021-01385
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): Y
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2020
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 10449H18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR