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

Catalog Number 1550350-08

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other additional 3 xience stents referenced are being filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat restenosis of 3 xience stents that were implanted in (b)(6) 2018.The stents were located in the left anterior descending (lad), circumflex and left main coronary arteries.The patient was symptomatic on (b)(6) 2019, with chest tightness and shortness of breath.An angiography was done to confirm restenosis and intervention was performed today, (b)(6) 2019.The 3.50x8 mm xience sierra was advanced with resistance noted with the previously implanted stents and once it was located in the proximal circumflex coronary artery it became stuck on one of the stents and could not be advanced or withdrawn.Finally the stent delivery system (sds) was able to be removed; however, the stent was not located on the sds when it came out of the anatomy.It was confirmed that the stent remained in the left main coronary artery and balloon angioplasty was used to crush the stent to the vessel.The patient remains hospitalized with a heart pump.No additional information was provided.

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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the previously implanted stents causing the reported failure to advance.During removal the device interacted with the previously implanted stents causing the reported difficulty to remove and subsequent stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9182917
• MDR Text Key: 163050045
• Report Number: 2024168-2019-12479
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227394
• UDI-Public: 08717648227394
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1550350-08
• Device Lot Number: 9062541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 UNKNOWN XIENCE STENTS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR