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

Catalog Number UNK XIENCE PROS

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Cardiac Arrest (1762); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The udi number is not known as the part and lot number were not provided.The additional xience pro device referenced in description of event or problem being filed under a separate medwatch report number.

Event Description

It was reported that the patient presented with chronic stable angina and the procedure was to treat a de novo lesion in the ramus interventricular anterior (riva), which is the left anterior descending (lad) artery, with 90% stenosis, heavy calcification and heavy tortuosity and the right circumflex (rcx) artery with heavy calcification as well but no tortuosity.The patient had a bifurcation stenosis of the rcx and riva.Kissing balloon technique was chosen for therapy.After that it was decided to implant a xience pros stent.The stent delivery system (sds) was introduced into the left main (lm) artery, where it detached from the balloon due to calcification.The stent was pulled back with the help of a second balloon over a second guidewire into the artery radialis, where it became deformed and couldn't be pulled out through the sheath, it was tangled in the artery.The dislodged stent remained in the artery.The procedure took a break and then the procedure started in the left arm.Two guidewires were placed in the riva and rcx.A second xience pros stent was implanted into the rcx, which was also somewhat more difficult to pass the lm artery than normal.The control showed multiple dissections in the lm, riva and rcx after the stent was re-dilated.The patient required resuscitation.Angiography was done.Thrombus was observed.When the patient became stable, the thrombus occluded riva was recanalized and showed blood flow again.The patient died on the operating table.In the physician's opinion, neither of the xience pros stents caused or contributed to the death.The patient died of asystole.No additional information was provided.

Manufacturer Narrative

The product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product were not performed because the part/lot numbers were not reported.The reported patient effects of cardiac arrest, thrombosis/thrombus, and death are listed in the xience sierra/pros everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation determined the reported difficulties and subsequent treatments appear to be related to the operational context of the procedure; however, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: XIENCE PROS 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: 16330633
• MDR Text Key: 309124862
• Report Number: 2024168-2023-01330
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE PROS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Life Threatening