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

Catalog Number	1145300-08
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is not returning for investigation.Investigation is not yet complete.A follow up report will be submitted with all relevant information.(b)(4).
Event or Problem Description
It was reported that the procedure was performed to treat a lesion with heavy tortuosity and moderate calcification in the obtuse marginal coronary artery.The xience alpine stent delivery system (sds) was advanced with resistance from the anatomy and before reaching the target lesion, the sds was unable to advance further.Resistance was noted during removal of the sds; therefore, force was used to remove the device.During removal, the stent dislodged from the balloon.The dislodged stent migrated and remains in the proximal circumflex artery.The physician decided to advance a 3.0 x 12 mm xience alpine sds to compress the dislodged stent to the vessel wall.The procedure was ended.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.It was reported that the device met resistance and use of force was applied.It should be noted that the xience alpine everolimus eluting coronary stent system (eecss), domestic electronic instructions for use states: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.It is unknown if the ifu deviation contributed to the reported event.The investigation determined the reported difficulties and subsequent treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: XIENCE ALPINE
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9130838
• Report Number: 2024168-2019-12170
• Device Sequence Number: 11258727
• Product Code: NIQ
• UDI-Device Identifier: 08717648200045
• UDI-Public: 08717648200045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/05/2019

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: 04/19/2021
• Device Catalogue Number: 1145300-08
• Device Lot Number: 8041241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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
• Patient Weight: 82