MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1550400-38
Medical Device Problem Codes	Stretched (1601); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A visual inspection was performed on the returned device.The reported material deformation and stent dislodgement were confirmed.The investigation determined the reported difficulties and subsequent treatments appear to be related to the operational context of the procedure, as it is likely that the device interacted with the guiding catheter which reportedly moved during deployment/balloon inflation causing the partially expanded stent to dislodge inside the guiding catheter.The stent delivery system was removed and the dislodged stent was retrieved from the patient anatomy with a snare device, contributing to the reported stent damage/material deformation during retraction.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.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the ostium of the proximal right coronary artery (rca).A non-abbott al type guiding catheter was advanced to the lesion.A 4.0x38mm xience sierra stent delivery system (sds) was then advanced to the lesion without resistance; however, the guiding catheter moved during the sds balloon inflation to deploy the stent, and the proximal end of the partially expanded stent entered the guiding catheter.The sds balloon inflation had stopped at approximately 5-6 atmospheres, and the partially expanded stent dislodged from the sds balloon and the proximal end of the stent remained in the guiding catheter.The sds was removed and the dislodged stent was retrieved from the patient anatomy with a snare device.After removal, the stent was noted to be stretched/mangled and twined with the snare device and the stent struts.A new same size xience sierra stent was implanted at the lesion and the procedure was completed.A clinically significant delay in the procedure was reported; however there was no patient sequela.The physician thinks the event was caused due to operational factors.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7874612
• Report Number: 2024168-2018-07164
• Device Sequence Number: 227863
• Product Code: NIQ
• UDI-Device Identifier: 08717648227547
• UDI-Public: 08717648227547
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

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: 03/25/2021
• Device Catalogue Number: 1550400-38
• Device Lot Number: 8031841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/13/2018
• 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