MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ESPRIT¿; SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE

Model Number	1203350-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pseudoaneurysm (2605); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The reported patient effects of bleeding and pseudoaneurysm are listed in the esprit btk everolimus eluting resorbable scaffold systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2025 two esprit btk scaffolds (both 3.5x38 mm) were implanted in the moderately calcified, right anterior tibial artery through the left groin access site.The patient's baseline hemoglobin was 8.5 g/dl.On (b)(6) 2025 the patient had a pseudoaneurysm, approximately 2.1 x1 cm in size in the left groin arising from the superficial femoral artery.The patient's hemoglobin level dropped to 6.6 g/dl.The patient was transferred to the intensive care unit for higher level of care to monitor the hemoglobin level.Four units of packed red blood cells and a prothrombin injection were administered.The patient was discharged home on (b)(6) 2025.No additional information was provided.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that in the opinion of the physician, the pseudoaneurysm arising from the superficial femoral artery, and related issues, was not caused by an abbott device.The physician used a suture to close the left groin procedural access site on 9/23/2025.Although the pseudoaneurysm, hemorrhage, administration of medication and blood transfusion are not related to the implanted scaffold, this event has been reported; therefore, it will remain reportable.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the case information and related record review, there was no device malfunction or adverse event associated with this device.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Corrections: h6 - health effect - clinical code: codes 1888 and 2605 were removed and code 4582 was added.H6 - health effect - impact code: codes 4641 and 4644 were removed and code 2199 was added.

• Brand Name: ESPRIT¿
• Common Device Name: SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23750764
• Report Number: 2024168-2025-11895
• Device Sequence Number: 21189361
• Product Code: NXW
• UDI-Device Identifier: 08717648357091
• UDI-Public: (01)08717648357091(11)250217(17)270216(10)5021761
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1203350-38
• Device Catalogue Number: 1203350-38
• Device Lot Number: 5021761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: HT COMMAND 18, 300 X .018; INTRODUCER SHEATH: 6F X 10 CM PINNACLE BY TERUMO; VESSEL CLOSURE: PERCLOSE DEVICE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic
• Patient Race: White