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

Model Number	1550300-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Stenosis (2263)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effects of angina and stenosis are listed in the xience sierra, everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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 manufacture, design or labeling of the device.
Event or Problem Description
(b)(6) study report.Patient id: (b)(6).It was reported that on (b)(6) 2019, the patient presented with elevated troponin.A 3.0x8mm and 3.5x8mm xience sierra stents were implanted in the ramus coronary artery with acceptable results.On (b)(6) 2019, the patient presented with chest pain.Per imaging, the left anterior descending (lad) and right coronary artery (rca) had an occlusion.The ramus coronary artery 3.0x8mm xience sierra stent was observed with in-stent restenosis.As treatment, another percutaneous coronary intervention (pci) was performed.The ramus was treated with a high-pressure balloon catheter.The pre-existing coronary artery bypass graft to the lad was patent.The patient was discharged home with continued dual antiplatelet therapy (dapt).There was no device malfunction.No additional information was provided regarding this issue.
Event or Problem Description
Subsequent to the previous medwatch report, the additional information was received: on (b)(6) 2020, the 3.5x8mm xience sierra stent was also observed restenosed, treated with a laser and balloon angioplasty.Medications were provided.
Additional Manufacturer Narrative
The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effects of angina and stenosis are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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 manufacture, design or labeling of the device.The 3.5x8mm xience sierra stent mentioned in b5 is filed under a separate medwatch report.
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.
Event or Problem Description
Subsequent to the previous medwatch report, the additional information was obtained: on (b)(6) 2020, the patient experienced chest pain.Coronary angiography revealed occluded left anterior descending (lad), circumflex and right coronary arteries.The graft was patent to the lad.The ramus had in-stent restenosis, treated with laser and high pressure balloon.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effects of dyspnea is listed in the xience sierra, everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
Subsequent to the previous medwatch report, the additional information was received: on (b)(6) 2020, the patient presented to the emergency room with chest pain and shortness of breath.Imaging was performed revealing an occluded lad, cx, and rca.The lima to the lad was patent and the ramus had in-stent restenosis treated with balloon angioplasty.The event resolved that same day and the patient was discharged home.

• 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: 9142228
• Report Number: 2024168-2019-12264
• Device Sequence Number: 19484658
• Product Code: NIQ
• UDI-Device Identifier: 08717648227233
• UDI-Public: 08717648227233
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2019
• Device Model Number: 1550300-08
• Device Catalogue Number: 1550300-08
• Device Lot Number: 8092541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 01/24/2020; 02/28/2020; 07/23/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 02/17/2020; 03/12/2020; 08/13/2020
• 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: 1 IMPLANTED XIENCE SIERRA STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 90