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

Catalog Number 1500225-23

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the stent of a 2.25 x 23 mm xience sierra stent delivery system (sds) dislodged from the balloon during an attempt to cross the lesion.An unsuccessful attempt to remove the stent with a lasso was made; therefore, the stent was crushed against the artery wall with an additional unspecified stent.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.Factors that may contribute to stent dislodgment, but are not limited to, interaction with other devices and/or device accessories and user handling damage.Based on the information provided, a definitive cause for the stent dislodgement cannot be determined.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: the patient was reported to be doing well post 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
• MDR Report Key: 8165386
• MDR Text Key: 130380874
• Report Number: 2024168-2018-09705
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Catalogue Number: 1500225-23
• Device Lot Number: 8062841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention