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

Catalog Number 1074300-18

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an unspecified lesion.After stent deployment of a 3.0x18mm xience xpedition, the stent-balloon failed to deflate.It was decided to simply withdraw the stent-balloon.No harm came to the patient.Reportedly, the device was not prepped (air aspiration) outside the anatomy prior to use.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was to treat a mildly tortuous, mildly calcified mid left anterior descending artery.A 3.0x18mm xience xpedition stent delivery system was inflated once at 18 atmopsheres.After stent deployment, the stent-balloon completely failed to deflate, although 5-10 seconds was held negative to deflate the balloon.It was decided to simply withdraw the stent-balloon.Some resistance was met with the guiding catheter and both were removed as a single unit.No harm came to the patient.Reportedly, the device was not prepped (air aspiration) outside the anatomy prior to use.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficulty to remove and deflation issues were not confirmed.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 incidents from this lot.It was reported xience xpedition was not prepped outside of the anatomy.It should be noted that the xience xpedition everolimus eluting coronary stent system instructions for use lists delivery system preparation to be performed prior delivery procedure.The investigation was unable to determine a conclusive cause for the reported deflation issues and difficulty to deflate as not issue was identified during return device analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8803242
• MDR Text Key: 151459321
• Report Number: 2024168-2019-10138
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162343
• UDI-Public: 08717648162343
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Catalogue Number: 1074300-18
• Device Lot Number: 9012441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1