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

Catalog Number	1550225-12
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.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 determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the successfully implanted stent interacted with the guide wire during removal causing the reported entrapment of a device.During the attempt to remove both guide wires from lesion the stent was explanted causing the reported device damaged by another with the patient effect of tissue damage.There is no indication of a product quality issue with respect to manufacture, design or labeling.The two extra s'port guide wires are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the patient underwent a coronary stenting procedure, treating a target lesion in the diagonal artery.The 2.25 x 12 mm xience sierra stent was implanted without issue.There was no difficulty noted during advancement or withdrawal of the stent delivery system.However, resistance was noted during removal of the extra s'port guide wire, as the guide wire was caught on the distal end of the stent.The guide wire coils stretched into the aorta.A guide liner was advanced into the guide catheter, in an attempt to push the coils back into the vessel.A second extra s'port guide wire was advanced to assist removal of the first guide wire.The second guide wire also got stuck on the stent.In the attempt to remove both guide wires, the stent was explanted with the guide wires.The left anterior descending (lad) artery was damaged during the removal attempts and an additional stent was implanted.The diagonal artery was not treated with additional stenting and no vessel damage was noted from the stent explantation.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9508070
• Report Number: 2024168-2019-14918
• Device Sequence Number: 1878419
• Product Code: NIQ
• UDI-Device Identifier: 08717648227004
• UDI-Public: 08717648227004
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: 08/27/2020
• Device Catalogue Number: 1550225-12
• Device Lot Number: 9082241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/20/2019
• 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