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

Catalog Number 1500400-38

Device Problems Difficult to Remove (1528); Material Rupture (1546); Difficult or Delayed Activation (2577); Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Cardiac Arrest (1762); Myocardial Infarction (1969); Occlusion (1984); Respiratory Failure (2484)

Event Date 07/31/2020

Event Type  Injury  

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.User facility medwatch report number (b)(4).

Event Description

User facility medwatch report received that states: "stent delivery balloon ruptured during inflation after approx 6-8 atmospheres of pressure; (b)(6) 2020 procedure - the intervention was complicated by technical malfunction of the 4.0 x 38 mm xience stent in the mid right coronary artery.The stent delivery balloon ruptured during inflation after approximately 6 to 8 atmospheres of pressure.This resulted in incomplete expansion of the stent.We were unable to remove the stent delivery balloon or get the device out through the guide catheter.Ultimately, it was further partially and asymmetrically deployed, as detailed below, using the ruptured balloon.With this complication, the patient developed bradycardiac cardia arrest, essentially with the transient asystole and subsequent severe bradycardia.Ultimately, she would require iv vasopressor and inotropic therapy, as wall as emergent intubation for airway support.Intubation was provided by the emergency room physician and subsequent airway management and vasopressor therapy guided by the critical care staff.With this complication, we also lost flow through the right coronary artery.Ultimately we were able to restore flow through the artery, but the patient did suffer an infraction as a result.".

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effects arrhythmia, occlusion, and myocardial infarction are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported material rupture; however, factors that may contribute to material ruptures include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.Removal of the delivery catheter was difficult as the device met resistance with the guiding catheter due to the ruptured balloon.The stent was ultimately implanted using the ruptured balloon; however, the reported delayed activation and subsequent issue with wall apposition were experienced.The reported patient effects and treatment appear to be related to operational context of the procedure.It should be noted that the device was not returned for analysis and although multiple attempts were made to attain further information, no information was provided.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA 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
• MDR Report Key: 10730173
• MDR Text Key: 213009556
• Report Number: 2024168-2020-08876
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500400-38
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability