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

Model Number	1550300-28
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Angina (1710); Occlusion (1984); Respiratory Distress (2045)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional xience sierra device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2018, the procedure was performed to treat the right coronary artery.Two xience sierra stents (2.75x38mm and 3.0x28mm) were implanted.On (b)(6) 2020, the patient underwent a heart catherization due to chest pain and trouble breathing.It was then confirmed that both stents had collapsed.The stents were opened with angioplasty and two new xience sierra stents (3.5x12mm and 3.5x28mm).There was no adverse patient sequela reported.No additional information was provided.
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 similar incidents from this lot.The reported patient effects of angina and occlusion are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported material deformation.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5/d6: the estimated implant date was changed from (b)(6) 2018 to (b)(6) 2018.
Event or Problem Description
It was reported that on (b)(6) 2018, the procedure was performed to treat the right coronary artery.Two xience sierra stents (2.75x38mm and 3.0x28mm) were implanted.On (b)(6) 2020, the patient underwent a heart catherization due to chest pain and trouble breathing.It was then confirmed that both stents had collapsed.The stents were opened with angioplasty and two new xience sierra stents (3.5x12mm and 3.5x28mm).There was no adverse patient sequela reported.No additional information was provided.As the implant date was not confirmed, the last date provided ((b)(6) 2018) will be used as the estimated date.

• 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: 10879892
• Report Number: 2024168-2020-09794
• Device Sequence Number: 11762700
• Product Code: NIQ
• UDI-Device Identifier: 08717648227288
• UDI-Public: 08717648227288
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 07/03/2019
• Device Model Number: 1550300-28
• Device Catalogue Number: 1550300-28
• Device Lot Number: 8062241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/28/2020
• 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: 2.75X38 XIENCE SIERRA
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention