MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1550400-08
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.(b)(4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.It was reported the xience sierra stent delivery system (sds) was inflated above the rated burst pressure of 16 atms.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use states: do not exceed rated burst pressure (rbp) as indicated on product label.Monitor balloon pressure during inflation.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the balloon catheter used to perform post-dilation interacted with the deployed stent causing the reported stent migration with the treatments of additional therapy/non-surgical treatment, additional therapy/delayed treatment, and removal of a foreign body.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a non-tortuous, non-calcified left main lesion.The 4.0x08mm xience sierra stent was deployed at 20 atmospheres.Post-dilatation was done with a 5.5x20mm non-abbott balloon and when the balloon was retrieved, the stent came back with it and became loose in the anatomy.The stent was retrieved with a snare device.There was a 1 hour 10 minutes delay in the procedure.A new non-abbott stent was used to treat the lesion.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9603727
• Report Number: 2024168-2020-00769
• Device Sequence Number: 16258011
• Product Code: NIQ
• UDI-Device Identifier: 08717648227479
• UDI-Public: 08717648227479
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

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 Catalogue Number: 1550400-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/17/2020
• 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: 77 YR