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

Catalog Number	1550400-38
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The stent remains in the patient.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to deploy.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the patient had a previously placed stent in a saphenous vein graft (svg) to the ostial posterior descending artery 10 years prior.This was another percutaneous coronary intervention to treat the same area.The lesion was a little eccentric with one focal stenosis at the ostium.During deployment of the xience sierra 4 x 38 mm stent at 10 atmospheres, the stent slipped back proximal toward the guide into the aorta.The ostial focal lesion was covered, however roughly 10mm of stent is now hanging outside the svg into the aorta.The stent balloon catheter was then re-advanced and inflated one more time to complete the procedure after taking a final angiogram.This was done to reinforce the stent to the vessel wall.The physician plans to keep patient on dual antiplatelet therapy for the remainder of his life.There was no reported adverse patient effect.There was no reported 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: 7887265
• Report Number: 2024168-2018-07263
• Device Sequence Number: 1939860
• Product Code: NIQ
• UDI-Device Identifier: 08717648227547
• UDI-Public: 08717648227547
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2019
• Device Catalogue Number: 1550400-38
• Device Lot Number: 8060741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR