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

Catalog Number 1011707-38

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) 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.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.Na.

Event Description

It was reported that the procedure was performed to treat a heavily tortuous and heavily calcified lesion in the mid left anterior descending artery.Resistance with the anatomy was felt when advancing a 2.5x38mm xience prime stent delivery system (sds).The sds was removed; however, resistance with the anatomy was felt and force was applied.The shaft separated and was simply withdrawn.The procedure was successfully completed with a new 2.5x38mm xience prime sds.There was no reported adverse patient effect or a clinically significant delay in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.Device code 2017 - excessive force.The device was returned for analysis.The reported difficult to advance and the reported difficult to remove were able to be confirmed.The reported material separation was confirmed.A review of the manufacturing records identified no nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other incidents.The xience prime instructions for use states: applying excessive force to the delivery system can potentially result in loss or damage to the stent and / or delivery system components.Although it was noted that physical resistance was met during retraction of the stent delivery system, this was due to the challenging anatomy; therefore the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.The investigation determined the reported failure to advance and difficult to remove appear to be related to procedural circumstances as it is likely that the device interacted with the challenging anatomy during advancement resulting in the reported failure to advance.Further interaction with the challenging anatomy during retraction of the device, as resistance was noted, likely contributed to the material separation.Based on the information reviewed and analysis of the returned device, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

Subsequent to the previously filed report, additional information was received reporting that the shaft separated at the proximal end.No additional information was provided.

• Brand Name: XIENCE PRIME
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8783137
• MDR Text Key: 150850357
• Report Number: 2024168-2019-10045
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2022
• Device Catalogue Number: 1011707-38
• Device Lot Number: 9021541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1