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

Model Number	1550250-23
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Intimal Dissection (1333); Angina (1710); Occlusion (1984); Stenosis (2263); Prolapse (2475)
Date of Event	11/12/2019
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 identified no other similar incidents from this lot.It should be noted that the reported patient effect(s) of dissection, stenosis, angina, prolapse and occlusion 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 determined a conclusive cause for the reported patient-device incompatibility wall apposition cannot be determined.The reported difficulties possibly contributed to the reported patient effects however a conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Patient id: (b)(4).It was reported that on (b)(6) 2019, the patient presented with in-stent restenosis from a previous percutaneous coronary intervention, located in the mid left anterior descending (lad) coronary artery.A side branch of the lad was occluded.Pre-dilatation was performed and a 2.5x23mm xience sierra stent (1550250-23, 9072241) was successfully implanted from the proximal-mid lad into the 1st anterolateral branch.The stent was fully apposed to the vessel wall except malposition involving the continuation of the mid lad distal to the takeoff of the 1st anterolateral.The side branch had become jailed after 2.5x23mm xience sierra stent implantation.Post-implantation, intra-stent minimal plaque protrusion and a minor, proximal lad dissection were observed, both of which did not require treatment.On (b)(6) 2020, the patient was admitted to the hospital for angina.On (b)(6) 2020, another pci was performed and in-stent restenosis (99%) was observed in the mid lad.Another stent was implanted as treatment and the event resolved without sequela.No additional information was provided regarding this issue.

• 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: 9983066
• Report Number: 2024168-2020-03789
• Device Sequence Number: 3940247
• Product Code: NIQ
• UDI-Device Identifier: 08717648227110
• UDI-Public: 08717648227110
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 04/21/2020

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: 07/25/2020
• Device Model Number: 1550250-23
• Device Catalogue Number: 1550250-23
• Device Lot Number: 9072241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/21/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 81