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

Catalog Number	1550350-33
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.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 other incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the calcified lesion causing the reported failure to advance.The device met resistance with the guide liner during removal causing the reported difficulty to remove and subsequent stent dislodgement with the patient effect of additional therapy/non-surgical treatment.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a calcified lesion in the proximal left anterior descending artery.A 3.5x33mm xience sierra stent delivery system (sds) was advanced; however, resistance with the anatomy was felt.An attempt to remove the sds was made, but resistance with the guideliner was felt and the stent dislodged at the distal end of the guideliner.A second balance wire was advanced past the dislodged stent and wrapped around the original guidewire.As a unit, the guideliner, stent, and wires were pulled back into the guide catheter.The guide catheter along with the retrieved equipment was then removed as a unit.The procedure was successfully completed with a new 3.25x33mm xience sierra stent.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 9324889
• Report Number: 2024168-2019-13604
• Device Sequence Number: 16712370
• Product Code: NIQ
• UDI-Device Identifier: 08717648227455
• UDI-Public: 08717648227455
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2020
• Device Catalogue Number: 1550350-33
• Device Lot Number: 9081341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 79