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

Catalog Number	1550300-12
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of angina, hypotension and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition).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 the design, manufacture or labeling of the device.The other xience sierra referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion at the bifurcation of the left anterior descending and diagonal coronary arteries.Post atherectomy and pre-dilatation with a non abbott balloon, a 3.00 x 12 mm xience sierra stent was successfully deployed in the diagonal coronary artery.Post deployment the bifurcation proximal to the implanted stent was further dilated using a kissing balloon technique with two non-abbott balloons.Post balloon angioplasty, a plaque shift was noted and an additional 3.00 x 12 mm xience sierra stent was deployed to successfully treat the plaque shift, with some overlap of the previously deployed stent.No post dilatation was performed.There was no clinically significant delay in the procedure.Ten minutes post procedure, the patient complained of chest pain and changes to the patient's blood pressure [drop] and ekg were noted.Angiography confirmed in stent thrombosis.The patient was fitted with a non-abbott temporary heart pump and an intravascular ultrasound was performed.Stent under expansion was noted and further balloon angioplasty with a 3.0 x 5 mm non abbott balloon dilatation catheter was performed.Post angioplasty, the expanded stents were confirmed to be patent and the patient was reported to be stable.The heart pump was removed later the same day.An extended hospital stay was required.The patient was on dual anti-platelet therapy at the time of the procedure; however, tests for the level of the protein p2y12 came back invalid and as a conservative measure the patient was switched to an alternative anti-platelet medication incase they were a non-responder.No additional information was reported.

• Brand Name: XIENCE SIERRA 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: 8039220
• Report Number: 2024168-2018-08461
• Device Sequence Number: 19228746
• Product Code: NIQ
• UDI-Device Identifier: 08717648227240
• UDI-Public: 08717648227240
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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: 05/02/2019
• Device Catalogue Number: 1550300-12
• Device Lot Number: 8042441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/05/2018
• 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: STENT: 3.00 X 12 MM XIENCE SIERRA
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR