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

Model Number	1550250-28
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
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.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 during advancement resistance was met with the eccentric anatomy resulting in the reported failure to advance.Manipulation/inadvertent mishandling resulted in the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat an eccentric lesion located in the proximal left anterior descending coronary artery that was non tortuous.When the xience sierra stent delivery system (sds) was being advanced on the balance middleweight guide wire, the proximal shaft separated outside the patient.The sds did not cross the lesion and another same size xience sierra was used to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9938514
• Report Number: 2024168-2020-03499
• Device Sequence Number: 2718253
• Product Code: NIQ
• UDI-Device Identifier: 08717648227127
• UDI-Public: 08717648227127
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 04/08/2020

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: 10/24/2020
• Device Model Number: 1550250-28
• Device Catalogue Number: 1550250-28
• Device Lot Number: 9101741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1