MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Model Number	1125400-12
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb gt1 referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a proximal circumflex artery into the first marginal.The patient came in to the hospital on (b)(6) 2017 for a routine check-up.Optical coherence tomography (oct) was used throughout the procedure.The vessel was determined to be greater than 2.5 mm.A rotoblader was used and multiple unspecified balloons were used for pre-dilatation.The residual stenosis was reduced to less than 40%.A 3.5 x 23 mm absorb scaffold was implanted; however, the center of the scaffold recoiled, so a 4.0 x 12 mm xience alpine stent was deployed over the scaffold for a bail-out and it also recoiled.Post-dilatation was performed with a nc trek balloon catheter.The final angiographic residual stenosis was 40-50%.Oct confirmed that the scaffold and stent were fully apposed to the vessel wall.On (b)(6) 2017, the patient returned with chest discomfort and thrombosis was observed in both the scaffold and the stent and into the marginal artery.Balloon angioplasty was performed to regain flow to the arteries.The patient had been on plavix and aspirin and the dual antiplatelet therapy (dapt) medication was changed to brilinta.The patient is stable.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A cine was received and reviewed by an abbott vascular clinical specialist.In conclusion: severely under-expanded absorb scaffold due to highly resistant in-stent restenosis (isr) lesion in a calcified vessel, requiring placement of another metallic des (xience) on top of the scaffold.Final result continued to show poor expansion by angiogram and oct showed final mld of less than 2.5mm.The thrombosis event occurring 5 days post procedure is most likely due to the under expansion of the lesion by the scaffold and metallic des.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.However, angina and thrombosis are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation determined a conclusive cause for the reported difficulty to deploy cannot be determined.Additionally, a conclusive cause for the reported patient effects, 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.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6432188
• Report Number: 2024168-2017-02493
• Device Sequence Number: 11038415
• Product Code: NIQ
• UDI-Device Identifier: 08717648199608
• UDI-Public: (01)08717648199608(17)191009(10)6100341
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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: 10/09/2019
• Device Model Number: 1125400-12
• Device Catalogue Number: 1125400-12
• Device Lot Number: 6100341
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 07/21/2017
• 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: SCAFFOLD: ABSORB
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention