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

Catalog Number	1550400-18
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The 3.5 x 8 mm xience sierra stent delivery system referenced in b5 is filed under a separate medwatch report number.Na.
Event or Problem Description
It was reported the procedure was performed to treat a lesion with moderate calcification and tortuosity in the left anterior descending (lad) coronary artery with a 4.0 x 18 mm xience sierra stent delivery system (sds).The 4.0 xience sierra sds was advanced but met resistance with the 6fr guiding catheter.Therefore, it was decided to remove the 4.0 xience sierra and resistance was met as well with the guiding catheter during withdrawal.Outside the patient anatomy, it was noted that the proximal end stent struts were flared.A 3.5 x 8 mm xience sierra sds was advanced and encountered the same resistance during advancing and withdrawal.The proximal end stent struts were flared as well.A new guiding catheter was advanced and a new 4.0 xience sierra was advances successfully to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter during advancement to and removal of the device causing the reported difficulty to advance, difficulty to remove and subsequent material deformation (stent flare).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8870392
• Report Number: 2024168-2019-10641
• Device Sequence Number: 1938412
• Product Code: NIQ
• UDI-Device Identifier: 08717648227509
• UDI-Public: 08717648227509
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 09/12/2019

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: 10/22/2019
• Device Catalogue Number: 1550400-18
• Device Lot Number: 8101741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR GUIDEZILLA; 6FR GUIDEZILLA
• Patient Age: 74 YR