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

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.In the absence of a reported part number, the udi cannot be calculated.Failure to follow steps/instructions.The device was not returned for analysis.It should be noted the xience sierra everolimus eluting coronary stent system instructions for use, states: deflate the balloon by pulling negative pressure on the inflation device.Confirm balloon deflation under fluoroscopy and wait 10 to 15 seconds longer.If during withdrawal of the catheter resistance is encountered, re-inflate the balloon up to nominal pressure and repeat the deflation steps to improve balloon rewrap.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot number was not provided.The investigation was unable to determine a conclusive cause for the reported balloon fold issue thus resulting in the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience sierra device referenced is being filed under separate medwatch report.

Event Description

It was reported that after implantation of the 3.5 and 4.0 sierra stents, negative pressure was held from 3-5 seconds to deflate the balloons.The balloons of the stent delivery systems (sds) were completely deflated; however, the balloons were noted to be flat.Strong resistance was met during retraction of both the sds through the guiding catheter.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: the xience sierra is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

• 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: 7201728
• MDR Text Key: 97907726
• Report Number: 2024168-2018-00439
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• 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