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

Model Number	1550350-28
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	03/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 investigation was unable to determine a conclusive cause for the reported material rupture.The reported patient effect of intimal dissection is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as a known patient effect of coronary stenting procedures.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 the procedure was to treat a heavily calcified, moderately tortuous, 99% stenosed, de novo lesion in the mid to right coronary artery (rca).A 3.5x28mm rx xience sierra stent delivery system (sds) was inflated to 16 atmospheres (atm) when the balloon ruptured, causing a dissection in the peripheral vessel.A 3.5x12mm xience sierra was used to treat the dissection.It was noted that the device was prepared inside the anatomy.There were no adverse patient sequela and no clinically significant delay in the procedure.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: 9938762
• Report Number: 2024168-2020-03503
• Device Sequence Number: 11442627
• Product Code: NIQ
• UDI-Device Identifier: 08717648227448
• UDI-Public: 08717648227448
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

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: 07/11/2022
• Device Model Number: 1550350-28
• Device Catalogue Number: 1550350-28
• Device Lot Number: 9070941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/08/2020
• 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