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

Model Number	1550400-08
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Damaged by Another Device (2915); Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat an eccentric lesion in the left main (lm) artery.A 4.0x8mm xience sierra stent delivery system (sds) was advanced to the lesion and deployed; however, it was noted under intravascular ultrasound (ivus) that the stent expansion was insufficient.Additional post dilatation was performed, but the stent became dislodged after interaction with a guide catheter and ended up in the aorta.The stent was removed with a snare and was noted to be stretched from the removal process; however, the physician is unsure if any of the xience sierra stent remains in the patient.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.An unspecified stent was implanted to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Only the stent implant was returned for analysis.The reported material deformation was able to be confirmed.The reported stent migration, the reported device damaged by another device and the reported patient-device incompatibility wall apposition were unable to be replicated in a testing environment due to the return condition of the stent implant.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 appear to be related to circumstances of the procedure as it is likely that since the device length was short (8 mm) the expansion ability was not enough resulting in the reported patient-device incompatibility wall apposition.Interaction with the guiding catheter resulted in the reported device damaged by another device and the reported stent migration.The treatment appears to be related to the operational context of the procedure as the stent was removed with a snare; thus resulting in the reported/noted material deformation.There was no separation noted to the stent implant.There is no indication of a product quality issue with respect to manufacture, design or labeling.Device length originally reported as 8cm was changed to 8mm.
Additional Manufacturer Narrative
Only the stent implant was returned for analysis.The reported material deformation was able to be confirmed.The reported stent migration, the reported device damaged by another device and the reported patient-device incompatibility wall apposition were unable to be replicated in a testing environment due to the return condition of the stent implant.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 appear to be related to circumstances of the procedure as it is likely that since the device length was short (8 cm) the expansion ability was not enough resulting in the reported patient-device incompatibility wall apposition.Interaction with the guiding catheter resulted in the reported device damaged by another device and the reported stent migration.The treatment appears to be related to the operational context of the procedure as the stent was removed with a snare; thus resulting in the reported/noted material deformation.There was no separation noted to the stent implant.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10: date device returned.

• Brand Name: XIENCE SIERRA 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: 10171573
• Report Number: 2024168-2020-05153
• Device Sequence Number: 3361045
• Product Code: NIQ
• UDI-Device Identifier: 08717648227479
• UDI-Public: 08717648227479
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2020

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: 05/09/2021
• Device Model Number: 1550400-08
• Device Catalogue Number: 1550400-08
• Device Lot Number: 804304A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020; 10/07/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/21/2020; 10/13/2020
• 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: GUIDING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 67