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

Model Number 1550250-38

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Stenosis (2263); Test Result (2695)

Event Date 06/26/2020

Event Type  Injury  

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 angina and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience sierra device referenced filed under separate medwatch report number.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2019, the patient presented with a recent non-st elevated myocardial infarction and a 70% stenosed lesion within the mid right coronary artery (rca).Pre-dilatation was performed within the mid rca and a 2.5x38mm (1550250-38, 9020841) and a 2.75x23mm (1550275-23, 8091141) xience sierra stent were implanted.Post-dilatation was performed.0% residual stenosis was noted without a device issue reported.On (b)(6) 2020, during a follow-up, the patient reported experiencing ongoing, intermittent chest pain that was relieved with rest.As treatment, the patient's medication (nitroglycerine) was provided/adjusted.On (b)(6) 2020, during a follow-up, the patient presented with worsening chest pain.Per nuclear stress test, st segment depression was observed.On (b)(6) 2020, the patient continued to have chest pain.The patient was hospitalized and in-stent restenosis was observed in both rca, xience sierra stents.As treatment, angioplasty was performed on the 99% occluded lesion within the rca.The event resolved.No additional information was provided regarding this issue.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: 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: 10454673
• MDR Text Key: 204425471
• Report Number: 2024168-2020-07117
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227141
• UDI-Public: 08717648227141
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2020
• Device Model Number: 1550250-38
• Device Catalogue Number: 1550250-38
• Device Lot Number: 9020841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XIENCE SIERRA STENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 47