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

Model Number	1550350-15
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulty to remove; however, difficulty to remove (guide wire) can be affected by numerous factors including, but not limited to, material damage, interactions with other devices and accessory product support.There is no indication of a product quality issue with respect to manufacture, design or labeling.The balance middleweight universal guide wire referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the right coronary artery (rca).The xience sierra stent delivery system was advanced over the balance middlweight universal guide wire.The xience sierra stent was deployed and no issues were noted.During removal of the stent delivery system, slight resistance was noted with the guide wire.There was no adverse patient effect or clinically significant delay.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: 11097781
• Report Number: 2024168-2020-11030
• Device Sequence Number: 896930
• Product Code: NIQ
• UDI-Device Identifier: 08717648227417
• UDI-Public: 08717648227417
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2020

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 Model Number: 1550350-15
• Device Catalogue Number: 1550350-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1