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

Catalog Number 1070350-38

Device Problems 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 02/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The location of the reported device was not provided; however, when information is received the investigation will be completed.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a totally occluded right coronary artery that was heavily calcified.An attempt was made to advance a 3.5 x 38 mm xience xpedition stent delivery system (sds) after balloon angioplasty was performed several times.However, the device failed to cross the lesion even when pre-dilatation was performed again.The device was then advanced against resistance; resulting in a shaft fracture [separation].Therefore, the device was replaced with an unspecified device 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

Internal file number - (b)(4).Mfr site: correction- reg#.Device code 2017 removed.Evaluation summary: the device was returned for analysis.The reported detachment was able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.A cine was received and reviewed by an abbott vascular clinical specialist.In conclusion, the images confirmed that the anatomy of the rca was extremely calcified and tortuous and may have been the cause for the xpedition stent not crossing.The no cross of the xpedition 3.5x38 mm stent was visible via cine; however, the cine images do not confirm the shaft breaking.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Manipulation of the device resulted in the noted multiple inner and outer member kinks and ultimately resulted in the reported detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, additional information was received.The device failed to cross the lesion due to the anatomy, and the shaft separated when advancing the device against resistance.There was no other device used to complete the procedure.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 8599372
• MDR Text Key: 144696452
• Report Number: 2024168-2019-03733
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Catalogue Number: 1070350-38
• Device Lot Number: 8100241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 90