AGENT
Report
- Report Number
- 2124215-2025-82133
- Event Type
- Death
- Date Received
- November 13, 2025
- Date of Event
- December 2, 2024
- Report Date
- February 4, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OOB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. B2. DATE OF DEATH WAS ESTIMATED BASED ON DEATH REPORTED AS OCCURRING IN (B)(6) 2025. B2. DATE OF DEATH AND H11 ADDITIONAL MFR NARRATIVE: CORRECTED.
IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2024, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATION WAS ADMINISTERED. THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS). THE TARGET LESION WAS LOCATED AT DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS 32 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. FOLLOWING PRE-DILATION USING A 2.50 MM X 15 MM BALLOON, THE LESION WAS SUCCESSFULLY TREATED WITH A 2.50 MM X 40 MM AGENT DCB DEVICE WITH 0% RESIDUAL STENOSIS AND TIMI FLOW 3. A LESION LOCATED AT MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 3.50 MM X 20 MM AGENT DCB DEVICE. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2025, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED.
IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2024, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATION WAS ADMINISTERED. THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS). THE TARGET LESION WAS LOCATED AT DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS 32 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. FOLLOWING PRE-DILATION USING A 2.50 MM X 15 MM BALLOON, THE LESION WAS SUCCESSFULLY TREATED WITH A 2.50 MM X 40 MM AGENT DCB DEVICE WITH 0% RESIDUAL STENOSIS AND TIMI FLOW 3. A LESION LOCATED AT MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 3.50 MM X 20 MM AGENT DCB DEVICE. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2025, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS FURTHER REPORTED THAT DURING 2.50 MM X 40 MM AGENT BALLOON INFLATION, MYOCARDIAL STAINING WAS NOTED, WHICH WAS MOST LIKELY ATTRIBUTABLE TO SMALL VESSEL PERFORATION. THERE WAS NO EVIDENCE OF FREE-FLOWING CONTRAST OR SIGNIFICANT EXTRAVASATION, AND THE STAINING REMAINED STABLE THROUGHOUT AND AFTER THE PROCEDURE.
IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2024, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATION WAS ADMINISTERED. THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS). THE TARGET LESION WAS LOCATED AT DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS 32 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. FOLLOWING PRE-DILATION USING A 2.50 MM X 15 MM BALLOON, THE LESION WAS SUCCESSFULLY TREATED WITH A 2.50 MM X 40 MM AGENT DCB DEVICE WITH 0% RESIDUAL STENOSIS AND TIMI FLOW 3. A LESION LOCATED AT MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 3.50 MM X 20 MM AGENT DCB DEVICE. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2025, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS FURTHER REPORTED THAT DURING 2.50 MM X 40 MM AGENT BALLOON INFLATION, MYOCARDIAL STAINING WAS NOTED, WHICH WAS MOST LIKELY ATTRIBUTABLE TO SMALL VESSEL PERFORATION. THERE WAS NO EVIDENCE OF FREE-FLOWING CONTRAST OR SIGNIFICANT EXTRAVASATION, AND THE STAINING REMAINED STABLE THROUGHOUT AND AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE 2.50 X 40 MM AGENT BALLOON WAS INFLATED ONCE AT 5 ATM FOR 90 SECONDS. TWENTY-FOUR DAYS LATER, PLEURITIC CHEST PAIN OCCURRED. THE PATIENT WAS HOSPITALIZED AND MEDICATION WAS GIVEN OR THE REGIMENT WAS ADJUSTED. THE EVENT WAS RESOLVED TWO DAYS LATER. STENT THROMBOSIS WAS ADJUDICATED PERTAINING TO THE DEATH OF UNKNOWN CAUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2248767 | AGENT | DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER | OOB | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Death |