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

Model Number	1550350-23
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified lesion in the moderately tortuous proximal left circumflex (plcx) coronary artery.The 3.50x23 mm xience sierra stent was attempted but could not cross the lesion due to the tortuous anatomy.The device was strongly pushed, causing the stent edge to flare.There was resistance met with the guiding catheter during removal.Another stent was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular 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 other similar incidents and/or complaints reported from this lot.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported failure to advance, difficulty to remove and stent damage appear to be related to operational circumstances of the procedure.Based on the reported information, during advancement the sierra sds encountered resistance with the mildly calcified and moderately tortuous anatomy resulting in the failure to advance.Mishandling of the device or the device being strongly pushed against resistance resulted in the reported stent damage and difficulty to remove from the guiding catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 10570909
• Report Number: 2024168-2020-07933
• Device Sequence Number: 19616465
• Product Code: NIQ
• UDI-Device Identifier: 08717648227431
• UDI-Public: 08717648227431
• Combination Product (Y/N): Y
• 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
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: 1550350-23
• Device Catalogue Number: 1550350-23
• Device Lot Number: 0061041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1