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

Catalog Number 1070300-18

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

(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 performed to treat a lesion in the moderately calcified, heavily tortuous, 90% stenosed right coronary artery.A 3x18mm xience xpedition was advanced to the lesion.The balloon of the stent failed to inflate and was losing pressure despite multiple unspecified indeflator devices.A new same sized xience xpedition stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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.Adverse event problem: device code 2017 - incorrect prep.The device was returned for analysis.The reported leak and inflation problems 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 similar incidents from this lot.Reportedly, the device was not prepped outside the patient prior to use.It should be noted that the xience xpedition everolimus eluting coronary stent system (eecss), instructions for use lists preparation to be performed prior to delivery procedure.The investigation was unable to determine a conclusive cause for the reported leak as no leak was identified during return device analysis; however, it is likely the leak was reported due to the inflation issues.The investigation determined the reported inflation issues appear to be related to circumstances of the procedure as it is likely the inner and outer member damage (stretched and wrinkled) noted during return device analysis likely reduced the inflation/deflation lumen and in combination with the moderately calcified, heavily tortuous, and 90% stenosed anatomy resulted in the reported inflation problem.It should be noted that although the inflation issue could not be confirmed during return analysis it is likely this is due to the operational context of the reported inflation issues which could not be replicated in a testing environment.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 1546 was removed.

Event Description

Subsequent to the initially filed report, the following information was received: the device was not prepped outside the anatomy, prior to use.The leak was located in the shaft, and the stent was removed along with the stent delivery system.No additional information was provided.

• 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: 8942378
• MDR Text Key: 155963972
• Report Number: 2024168-2019-11301
• Device Sequence Number: 1
• Product Code: NIQ
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2022
• Device Catalogue Number: 1070300-18
• Device Lot Number: 9020441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1