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

Catalog Number	1550225-18
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Reinsertion.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.Review of the complaint history did not indicate a lot specific quality issue.It should be noted that the xience xpedition everolimus eluting coronary stent system instruction for use states: an unexpanded stent may be retracted into the guiding catheter one time only.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The device was then removed, post dilation was performed, and then the device was reinserted (against instructions for use).Resistance was met with a previously implanted stent causing the reported difficulty to remove and subsequent patient effects of foreign body in patient.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 2.75x33 xience sierra stent was implanted in the mid right coronary artery (rca).The 2.25x18 xience sierra stent delivery system (sds) was inserted to treat the heavily tortuous, distal rca, but it met resistance with the mid rca stent.When resistance was met, the doctor stopped and removed the sds from the anatomy.The mid rca stent was post dilated with a 3.0 mm diameter balloon.The 2.25x18 sds was re-inserted, but met resistance with the mid rca stent.This time, the sds was stuck in the 2.75x33 stent and was unable to be removed.The 2.25x18 stent was implanted inside the 2.75x33 stent.There were no further attempts to treat the distal rca.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: 7641828
• Report Number: 2024168-2018-05070
• Device Sequence Number: 2512813
• Product Code: NIQ
• UDI-Device Identifier: 08717648227028
• UDI-Public: 08717648227028
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 04/26/2019
• Device Catalogue Number: 1550225-18
• Device Lot Number: 8041141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 2.75X33 MM XIENCE SIERRA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 82