MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070350-48

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/10/2021

Event Type  Injury  

Event Description

It was reported that the patient presented with an inferior wall myocardial infarction and the procedure was to treat a 30% stenosed with heavy thrombus and mildly calcified vessel in the right coronary artery (rca).The 3.5x48mm xience xpedition stent delivery system (sds) reached the target lesion and was deployed with a pressure of 10 atmospheres (atms), however, there was moderate resistance as the balloon was stuck to the stent post-deployment during removal.While retrieving the sds, half of the balloon material was left in the artery.The separated portion is partially floating in the aorta and the rest of the balloon material is stuck in the stent implanted in the rca.The proximal part was withdrawn easily.The physician tried to retrieve the balloon with a snare device but was unsuccessful.Re-occlusion occurred.It was noted that the total procedure time extended to 6 hours.Patient is still admitted in the hospital with oxygen support.Prolonged hospitalization led to right ventricular failure & hypotension, cardiogenic shock, metabolic acidosis, thrombocytopenia with platelet count of 32,000, anemia (hemoglobin 7) and acute kidney injury with creatinine 2.3.No additional information was provided.

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

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.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of occlusion and hypotension are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the deflated balloon interacted with the deployed stent during removal causing the reported difficulty to remove and subsequent material separation.The reported patient effects and treatment appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the patient presented with an inferior wall myocardial infarction and the procedure was to treat the right coronary artery (rca).The 3.5x48mm xience xpedition stent delivery system (sds) was deployed with a pressure of 10 atmospheres (atms), however, while retrieving the sds half of the balloon material was left in the artery.The physician tried to retrieve the balloon with a snare device but was unsuccessful.Re-occlusion occurred.Patient is still admitted in the hospital with oxygen support.Subsequent to the initially filed report, the following information was provided: it was reported that the procedure was to treat a 30% stenosed with heavy thrombus and mildly calcified vessel.The sds reached the target lesion, however, there was moderate resistance as the balloon was stuck to the stent post-deployment during removal.The separated portion is partially floating in the aorta and the rest of the balloon material is stuck in the stent implanted in the rca.The proximal part was withdrawn easily.It was noted that the total procedure time extended to 6 hours.Prolonged hospitalization led to right ventricular failure & hypotension, cardiogenic shock, metabolic acidosis, thrombocytopenia with platelet count of 32,000, anemia (hemoglobin 7) and acute kidney injury with creatinine 2.3.No additional information was provided.

• Brand Name: XIENCE XPEDITION 48 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: 13157339
• MDR Text Key: 288134305
• Report Number: 2024168-2022-00042
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070350-48
• Device Lot Number: 1072041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG