MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1145300-38
Medical Device Problem Codes	Off-Label Use (1494); Stretched (1601); 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	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat the tibial trunk.A 3x38 xience alpine drug eluting stent (des) was removed from its packaging without issue and advanced into the anatomy.When the balloon was inflated under fluoroscopy, it was noted that there was no stent attached.The stent was found stretched on the stylet outside of the patient anatomy.The user did not confirm that there was a stent on the balloon prior to use.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: device code 1494: coronary stent used in the periphery.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.It was reported that the procedure was to treat the tibial trunk.It should be noted that the xience alpine, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients.It is unknown if the ifu deviation contributed to the reported event.It was reported that the xience alpine stent delivery system was advanced to the lesion; however, upon inflation, it was noted that there was no stent attached.It was confirmed that the stent dislodged during preparation phase.Additionally, the ifu specifies: prior to using the xience alpine stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.It is unknown the ifu deviation contributed to the reported event.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE ALPINE OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10687507
• Report Number: 2024168-2020-08655
• Device Sequence Number: 303932
• Product Code: NIQ
• UDI-Device Identifier: 08717648200113
• UDI-Public: 08717648200113
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 09/10/2022
• Device Model Number: 1145300-38
• Device Catalogue Number: 1145300-38
• Device Lot Number: 9090541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 54