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

Catalog Number	1550275-15
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 3.75x8mm nc trek bdc is being filed under a separate medwatch report.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 other incidents.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition); however, the subsequent treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a de novo, heavily calcified, eccentric lesion in the heavily tortuous, proximal right coronary artery.A 2.75x15 mm xience sierra stent was implanted and after confirmation with intravascular ultrasound (ivus), the stent was found to be mal-apposed.There were no other issues noted with the xience sierra stent.A 3.75x8 mm nc trek balloon dilatation catheter (bdc) was used for post dilatation; however, the bdc could not cross the lesion due to resistance with the lesion.Resistance was felt with the lesion during removal of the bdc.No damage was noted to the nc trek bdc.A non-abbott bdc was used to complete the procedure and the xience sierra was fully apposed to the vessel wall.No damage was noted to the stent implant.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

• 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: 8026677
• Report Number: 2024168-2018-08336
• Device Sequence Number: 11061478
• Product Code: NIQ
• UDI-Device Identifier: 08717648227509
• UDI-Public: 08717648227509
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 06/05/2021
• Device Catalogue Number: 1550275-15
• Device Lot Number: 8052542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/31/2018
• 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: Required Intervention