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

Model Number	1550350-08
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.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 re-stenosed lesion located in the left anterior descending coronary artery that was heavily calcified and moderately tortuous.After the xience sierra stent delivery system (sds) failed to cross the heavily calcified anatomy, when the sds was removed with resistance, the proximal shaft separated outside the patient but was easily removed.There was no reported adverse patient effect and no clinically significant delay in the procedure.Different guide wires and balloons were used to better prepare the vessel.Then, another 3.5 x 8 mm xience sierra stent was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement resistance was met with the heavily calcified and moderately tortuous anatomy resulting in the reported failure to advance.Interaction and/or manipulation of the device ultimately resulted in the reported shaft separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.B1, b2: filed incorrectly as an adverse event d10, h3: device was not available for evaluation.

• 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: 10106937
• Report Number: 2024168-2020-04655
• Device Sequence Number: 11587666
• Product Code: NIQ
• UDI-Device Identifier: 08717648227394
• UDI-Public: 08717648227394
• Combination Product (Y/N): Y
• 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): 06/16/2020

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: 09/18/2020
• Device Model Number: 1550350-08
• Device Catalogue Number: 1550350-08
• Device Lot Number: 9091141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/16/2020
• 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: Other; Required Intervention
• Patient Age: 75 YR