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

Model Number	1550250-38
Medical Device Problem Codes	Leak/Splash (1354); Off-Label Use (1494); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported activation failure including expansion failures/inflation problem and leak/splash was confirmed.It was reported that the procedure was performed to treat a lesion in the tibial artery.It should be noted that the xience sierra, everolimus eluting coronary stent system, instructions for use (ifu) states: the xience sierra everolimus eluting coronary stent system is indicated for improving coronary luminal diameter in the following: patients with symptomatic ischemic heart disease due to discrete de novo native coronary lesions.For restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset.For the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches.For the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions; and coronary artery bifurcation lesions.It is unknown if the ifu deviation contributed to the reported event.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.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 tibial artery.A 2.5x38mm xience sierra stent delivery system (sds) was prepped (air aspirated) prior to use without issues.The sds was advanced; however, once at the lesion site the balloon couldn't inflate and the device was slowly leaking pressure.The leak location was unknown.The sds was removed with the stent on the sds.The procedure was successfully completed with a new 2.5x38mm xience sierra stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 10674300
• Report Number: 2024168-2020-08564
• Device Sequence Number: 2737640
• Product Code: NIQ
• UDI-Device Identifier: 08717648227141
• UDI-Public: 08717648227141
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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
• 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: 03/23/2021
• Device Model Number: 1550250-38
• Device Catalogue Number: 1550250-38
• Device Lot Number: 0031141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial 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
• Patient Age: 59 YR