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

Catalog Number 1070250-33

Device Problems Deflation Problem (1149); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2021

Event Type  Injury  

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 other similar incidents from this lot. Balloon deflation can be affected by, but not limited to, manufacturing damage, contrast mixing, bent/kinked shaft while inside the anatomy affecting the inflation/deflation lumen and/or stretched outer member (om) thereby reducing the inflation/deflation lumen. There was no damage noted to the device during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties. It is possible that a sufficient amount of time was not allowed to fully deflate the balloon before an attempt to withdraw the device resulting in compromising the inflation/deflation lumen; thus resulting in the reported deflation problem and the reported entrapment of device; however this cannot be confirmed. The investigation determined a conclusive cause for the reported difficulties cannot be determined. The treatment appears to be related to the operational context of the procedure as the balloon was punctured and taken out. There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a mildly calcified, mildly tortuous and 90% stenosed lesion in the left anterior descending coronary artery. The xience xpedition stent system was advanced to the lesion. The stent balloon was inflated to 12 atmospheres and the stent deployed and implanted; however, the balloon failed to deflate and was stuck in the patient. The balloon was then punctured and taken out. There was no adverse patient effect or a clinically significant delay in procedure. A non-abbott stent was implanted to complete the procedure. The patient was fine at the end of the procedure. No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 11478225
• MDR Text Key: 239662161
• Report Number: 2024168-2021-02015
• 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: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1070250-33
• Device Lot Number: 0042241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 03/12/2021 Patient Sequence Number: 1