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

Catalog Number	1550275-33
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.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 should be noted, the xience sierra everolimus eluting coronary stent system instructions for use states: do not prepare or pre-inflate the delivery system prior to stent deployment other than as directed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the inadvertent dilation of the balloon (against instructions for use) caused the stent to interact with the guiding catheter during advancement.It is likely the interaction with the guiding catheter caused the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a concentric lesion in the proximal to mid left anterior descending coronary artery with mild tortuosity, mild calcification and 99% stenosis.A 2.75 x 33 mm xience sierra stent delivery system (sds) was attempted to be advanced with no reported resistance; however, on angiography it was noted that the stent was not mounted on the balloon and had dislodged in the guiding catheter.The dislodged stent was retrieved by simply removing the guiding catheter, and the procedure successfully completed with a new 2.75 x 33mm xience sierra sds.On review of angiography one day post procedure, it was noted that the sds had inadvertently been dilated during the procedure, and the stent was no longer mounted on the balloon during advancement to the lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 8383943
• Report Number: 2024168-2019-01611
• Device Sequence Number: 1991025
• Product Code: NIQ
• UDI-Device Identifier: 08717648227219
• UDI-Public: 08717648227219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2019
• Device Catalogue Number: 1550275-33
• Device Lot Number: 804234A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1