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

Catalog Number 1550300-15

Device Problems Difficult or Delayed Positioning (1157); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

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.The investigation determined the reported difficulty to position appears to be related to circumstances of the procedure as it is likely the identified cardiac movement caused the reported visibility issues and subsequent difficulty to position.Additionally, the investigation was unable to determine a conclusive cause for the reported material deformation (stent shortening).A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that this was a percutaneous intervention to treat a heavily calcified lesion in the left anterior descending (lad) to left circumflex coronary artery bifurcation site.Reportedly, the procedure had a lot of cardiac drift and imaging was difficult due the cardiac motion.Following atherectomy, the 3.0x15mm xience sierra rx stent delivery system advanced to the ostium lad lesion site without any issues and the stent was deployed.Although there was no issue with deployment, the implanted stent did not appear to be deployed in the intended area due to the amount of proximal and distal drift attributed to the patient's natural cardiac movement.Post-dilatation was performed as planned by using an unspecified 3.25x12mm balloon dilatation catheter.Following post-dilatation, imaging revealed that the stent was now at the initially intended deployment area at the lad ostium, and it was the opinion of the physician that the stent length consequently shortened and fit within the intended area.No further treatment was provided.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8166692
• MDR Text Key: 130489600
• Report Number: 2024168-2018-09728
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227257
• UDI-Public: 08717648227257
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1550300-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1