MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Device Problems Material Rupture (1546); Difficult or Delayed Activation (2577)

Patient Problem Occlusion (1984)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimated.Implant date - estimated.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during an intervention in the coronary artery bypass graft, the xience stent was advanced to the lesion, but upon stent deployment, the balloon ruptured.The stent was not fully deployed, could not be further post-dilated, and remained in the vessel under deployed where it was attempted to be deployed in the graft.This resulted in the graft becoming occluded.Sometime later, the patient was re-hospitalized for further intervention.There was no additional information provided.

Manufacturer Narrative

Internal file number - (b)(4).The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effect of occlusion is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported material rupture.The reported difficulty to deploy appears to be related to circumstances of the procedure as it is likely the material rupture prevented the balloon from fully expanding the stent, causing the reported difficulty to deploy (wall apposition) with the patient effects of occlusion.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8426940
• MDR Text Key: 139035233
• Report Number: 2024168-2019-02070
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/16/2019
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention