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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Myocardial Infarction (1969); Nausea (1970); Stenosis (2263); Thrombosis/Thrombus (4440)
Date of Event	06/26/2019
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 did not indicate a lot specific quality issue.The reported patient effects of myocardial infarction, nausea and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.Factors that may contribute to patient-device incompatibility (wall apposition) include, but are not limited to, incorrect device size for lesion, patient anatomical morphology, patient disease state, and insufficient post-dilation.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition).A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Patient id: (b)(6).It was reported that the procedure was performed on (b)(6) 2019, treating a target lesion in the mid right coronary artery (rca).A 3.0 x 33 mm xience sierra stent and a 3.0 x 28 mm xience sierra stent were implanted.On (b)(6) 2019, the patient presented with chest pain, shortness of breath and nausea.Electrocardiogram was performed, confirming st elevation myocardial infarction.Angiography revealed that the 3.0 x 28 mm xience sierra stent was under-deployed and in-stent restenosis was noted.Medications were administered.A revascularization procedure was performed and the event resolved on (b)(6) 2019.No additional information was provided.
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 did not indicate a lot specific quality issue.The reported patient effect of myocardial infarction, nausea, angina and thrombosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition).A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: health effect - clinical code - code 2263 was removed.
Event or Problem Description
Ilumien iv study patient id: (b)(6).Subsequent to the initial report, it was noted that this event is a duplicate of a previously reported event, captured under (b)(6) (mfr report # 2024168-2019-10413).It was reported that on (b)(6) 2019, the patient underwent a coronary procedure to treat a target lesion in the mid right coronary artery (rca).A 3.0 x 33 mm xience sierra stent was implanted in the distal rca and a 3.0 x 28 mm xience sierra stent was implanted in the proximal rca.The stents were not implanted in overlapping fashion.Stent underexpansion was noted with both stents.The 3.0 x 33 mm xience sierra in the distal lesion was treated with additional balloon angioplasty and the final minimal stent area (msa) was 5.1 mm.The 3.0 x 28 mm xience sierra in the proximal lesion was also treated with additional balloon angioplasty; however, the stent remained under expanded.On (b)(6) 2019, the patient presented to the emergency room with severe retrosternal chest pain, that radiated down both arms.The chest pain was associated with shortness of breath and nausea.An electrocardiogram (ekg) was performed and noted st elevation, consistent with acute myocardial infarction due to acute thrombotic occlusion of the proximal under expanded xience sierra stent.Medications were administered.The patient underwent a revascularization procedure, with angioplasty of the proximal rca stent.The under expansion of the proximal stent was felt to be due to heavy calcification in the vessel.The patient was re-hospitalized on (b)(6) 2019 for shockwave lithotripsy, in an effort to disrupt the calcium to allow full extension of the stent.Despite the intervention, the stent under expansion was better, but was still consistent with under expansion.Post procedure, the patient was doing well.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16134576
• Report Number: 2024168-2023-00367
• Device Sequence Number: 12650499
• Product Code: NIQ
• UDI-Device Identifier: 08717648227288
• UDI-Public: 08717648227288
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: 10/31/2019
• Device Model Number: 1550300-28
• Device Catalogue Number: 1550300-28
• Device Lot Number: 8102341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White