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

Catalog Number	1550325-38
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Prolapse (2475)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.It should be noted that the reported patient effect of prolapse is listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as known patient effect of coronary stenting procedures.The investigation determined the reported difficult to deploy (wall apposition) appears to be related to the operational context 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 this was a percutaneous intervention treating a mid left anterior descending (lad), severely calcified long lesion with heavy plaque burden.A 3.5x38mm xience sierra stent was implanted without issue when prolapsed material was observed through the implanted stent struts, resulting in poor wall apposition.There was no thrombus but rather plaque without any embolization noted.As treatment balloon angioplasty was performed and another stent was implanted.This resolved the issue and the patient remained in stable condition.No additional information was provided regarding this issue.

• 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: 7846587
• Report Number: 2024168-2018-06882
• Device Sequence Number: 1313696
• Product Code: NIQ
• UDI-Device Identifier: 08717648227387
• UDI-Public: 08717648227387
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/05/2018

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: 04/16/2019
• Device Catalogue Number: 1550325-38
• Device Lot Number: 8032941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/05/2018
• 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
• Patient Age: 56 YR
• Patient Weight: 153