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

Model Number	1550400-28
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The reported patient effect of intimal dissection is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported failure to advance and subsequent treatment appears to be related to the operational context of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that during a heavily calcified right coronary artery intervention, the 4.0 x 28 mm xience sierra stent delivery system was advanced into the patient anatomy; however, due to the patient anatomy, the device was unable to cross to the target lesion.The device was removed without resistance and angiography noted a dissection, presumed to be caused during the xience sierra failure to cross.The physician implanted a 4.0 x 33 mm xience sierra stent to treat the dissection and the target lesion.Intravascular ultrasound (ivus) noted that the dissection was sealed and the target lesion was fully treated.There was no adverse patient sequela and no 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: 10532684
• Report Number: 2024168-2020-07693
• Device Sequence Number: 14346484
• Product Code: NIQ
• UDI-Device Identifier: 08717648227523
• UDI-Public: 08717648227523
• Combination Product (Y/N): Y
• 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): 09/14/2020

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: 05/18/2021
• Device Model Number: 1550400-28
• Device Catalogue Number: 1550400-28
• Device Lot Number: 0051241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/14/2020
• 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: 81 YR
• Patient Weight: 83