MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1011710-33

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

Patient Problems Ischemia (1942); Pain (1994); Thrombosis/Thrombus (4440)

Event Date 09/23/2023

Event Type  Injury  

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2023 one 3.0x38 mm xience prime stent was implanted in the right anterior tibial artery (ata) and one 3.5x33 xience prime stent was implanted in the right peroneal artery.The patient was on dual antiplatelet medications.Eleven days after the stent procedure, the patient had lower limb ischemia, right foot pain at rest and dusky toes, resulting in hospitalization.Ultrasound showed 100% occlusion of sfa (superficial femoral artery), popliteal and ata stented vessel with no run off, and thrombus was found in both implanted xience prime stents and in the non-study sfa.Revascularization was performed on (b)(6) 2023 in the study lesions, anterior tibial artery and peroneal artery, with thrombectomy performed; however, the clot was unable to be extracted.Direct thrombolysis was performed.Revascularization was performed on (b)(6) 2023 in the study lesions, anterior tibial artery and peroneal artery, with thrombectomy performed; however, there was minimal success and thrombolysis was continued.On 09/25/2023, revascularization, balloon angioplasty, was also performed in the non-study sfa.Angiogram showed improved flow to all vessels.Rivaroxaban was started.The patient was discharged to home on 09/28/2023.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of ischemia, pain and thrombosis are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent 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.The additional xience prime device referenced in b5 is filed under a separate medwatch report number.

• Brand Name: XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18056821
• MDR Text Key: 327181609
• Report Number: 2024168-2023-12177
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1011710-33
• Device Lot Number: 3061341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• 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
• Treatment: 3.0X38 XIENCE PRIME STENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 103 KG