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

Catalog Number 1500400-38

Device Problems Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a non-calcified lesion in the right coronary artery (rca).The xience sierra stent system crossed the lesion, but after inflation at nominal pressure, only a portion of the stent was apposed to the vessel wall.Only partial inflation was suspected.The xience sierra balloon was removed and a non-abbott balloon was used at 22 bars to fully appose the stent to the vessel with a good result.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.Subsequent information received: the physician gave additional information stating that this was a technical mistake from him.Part of the stent was still inside the guiding catheter during deployment, so this is the reason why this part was not well deployed.

Manufacturer Narrative

Internal file number - (b)(4).The stent remains in the vessel; the delivery system was not returned for analysis.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.It should be noted the xience sierra everolimus eluting coronary stent system (eecss), instructions for use (ifu) states: advance the delivery system over the guide wire to the target lesion under direct fluoroscopic visualization.Utilize the radiopaque balloon markers to position the stent across the lesion.Perform angiography to confirm stent position.If the position of the stent is not optimal, it should be carefully repositioned or removed.The balloon markers indicate both the stent edges and the balloon shoulders.Expansion of the stent should not be undertaken if the stent is not properly positioned in the target lesion.It should be noted that the physician made a technical mistake as the device was deployed partially inside the guiding catheter (against instructions for use).The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8244385
• MDR Text Key: 132944187
• Report Number: 2024168-2019-00323
• 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: 03/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Catalogue Number: 1500400-38
• Device Lot Number: 8070641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DILATATION CATHETER: RYUJIN TERUMO 4.0X20MM; DILATATION CATHETER: RYUJIN TERUMO 4.0X20MM
• Patient Outcome(s): Required Intervention