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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION AGENT CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
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.
 
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Brand NameAGENT
Type of DeviceCATHETERS, 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 Key11293234
MDR Text Key230712577
Report Number2134265-2021-01385
Device Sequence Number1
Product Code LOX
Combination Product (y/n)Y
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/22/2020
Device Model Number3825
Device Catalogue Number3825
Device Lot Number10449H18
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 Received01/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/08/2021 Patient Sequence Number: 1
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