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

Catalog Number	1550225-15
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	Respiratory Failure (2484); Foreign Body In Patient (2687)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, heavily calcified, lesion in the left anterior descending coronary artery (lad).Two unspecified sierra stents were implanted in the proximal to mid lad, without issues.There was residual stenosis distally, therefore a 2.25 x 15mm xience sierra stent delivery system (sds) was advanced.The 2.25 x 15 mm sds crossed through one implanted sierra stent but did not fully cross through the other implanted sierra stent.The lesion was further dilated with a 2.0 balloon, and an attempt was made to deliver the sds again, with no success.Resistance was met with the guide catheter during removal and the sds did not retract into the guide catheter.It is suspected the stent became damaged.The devices were removed together as a single unit.Following removal, it was observed that stent was no longer on the sds and had dislodged in the patient.The stent was caught inside the implanted sierra stent.Attempts to retrieve, deploy, or crush the stent were unsuccessful.The patient was sent to surgery and a coronary artery bypass graft (cabg) was performed.The stent was not found during the cabg.The patient developed acute respiratory distress syndrome and was placed on a ventilator all weekend.The patient was extubated on monday and is doing okay.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 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.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu), states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Additionally the eifu states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damaging or dislodging the proximal stent.It is unknown if the ifu deviations directly caused or contributed to the reported event.The investigation determined the reported difficulties and subsequent treatments appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 9343881
• Report Number: 2024168-2019-13745
• Device Sequence Number: 2269124
• Product Code: NIQ
• UDI-Device Identifier: 08717648227011
• UDI-Public: 08717648227011
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 09/02/2020
• Device Catalogue Number: 1550225-15
• Device Lot Number: 9082741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/19/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANTED SIERRA STENTS (X2)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 71 YR
• Patient Weight: 112