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

Catalog Number	1074275-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.The reported material deformation was able to be confirmed.The reported difficulty to remove was unable 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 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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced, resistance was met with the lesion resulting in the reported failure to advance.As the device was being removed, interaction with the rotating hemostatic valve (rhv) resulted in the reported/noted stent strut damages (bent, overlapped) thus resulting in the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a 2.75 x 28 mm xience xpedition stent delivery system (sds) was advanced to the lesion and would not cross.Upon removal of the sds from the guide catheter, one of the stent struts was found to be bent.Another xience sds was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.Additional information received states: the stent went into the guiding catheter smoothly, but when it was being removed, resistance was met at the rotating hemostatic valve, but it passed through.When the sds was removed, the stent damage was observed.No additional information was provided.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6872825
• Report Number: 2024168-2017-07527
• Device Sequence Number: 820079
• Product Code: NIQ
• UDI-Device Identifier: 08717648162268
• UDI-Public: 08717648162268
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: 1074275-28
• Device Lot Number: 7032441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1