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

Model Number	1550250-23
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 reported patient effect of intimal dissection is listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulty to advance appears to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified, mildly tortuous and stenosed artery causing the reported difficulty to advance.The investigation was unable to determine a conclusive cause for the reported material rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the mid-left anterior descending coronary artery that was heavily calcified, mildly tortuous and 90% stenosed.After lesion pre-dilatation, a xience sierra stent was advanced with resistance to the lesion and during stent deployment, the balloon ruptured at 12 atmospheres.The stent delivery system was removed from the anatomy without issue and a proximal dissection was observed.Another xience stent was implanted as treatment.There was no adverse patient sequela or a 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: 9723269
• Report Number: 2024168-2020-01588
• Device Sequence Number: 2400995
• Product Code: NIQ
• UDI-Device Identifier: 08717648227110
• UDI-Public: 08717648227110
• 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): 02/18/2020

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: 04/10/2021
• Device Model Number: 1550250-23
• Device Catalogue Number: 1550250-23
• Device Lot Number: 8032341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/18/2020
• 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