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

Model Number	1550275-15
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device is expected to be returned for investigation.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 this was a procedure to treat a lesion with mild calcification and mild tortuosity in the left anterior descending (lad) coronary artery.During advancement of the xience sierra stent delivery system (sds) through the guiding catheter, there was resistance and the proximal shaft separated in two pieces.The distal shaft remained in the guiding catheter; therefore, the complete sds was removed from the patient anatomy.A new sds was advanced through the guiding catheter with no issue and the procedure was completed successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficulty to advance and material separation were not confirmed.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to advance and material separation as neither reported issues were confirmed during return device analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.E1 - region state updated from 'na' to 'ga'.

• Brand Name: XIENCE 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: 9335808
• Report Number: 2024168-2019-13680
• Device Sequence Number: 1724560
• Product Code: NIQ
• UDI-Device Identifier: 08717648227172
• UDI-Public: 08717648227172
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/06/2020

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: 07/07/2020
• Device Model Number: 1550275-15
• Device Catalogue Number: 1550275-15
• Device Lot Number: 9070241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 93