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

Catalog Number 1070350-33

Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2019

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 device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a 90% stenosed, non-tortuous, and non-calcified lesion in the mid right coronary artery (rca).A 3.5x33mm xience xpedition stent delivery system (sds) was not prepped (air aspirated) outside the anatomy prior to use.The sds was advanced to the lesion and inflated to 12 atmospheres for 10 seconds; however, the balloon would not deflate after a negative was held for 10 seconds.A cutting balloon was advanced to puncture the sds balloon and the sds was removed.The procedure was successfully completed with a 4.0x15mm xience xpedition stent being deployed in the proximal rca overlapping the 3.5x33mm xience xpedition sds for about 2-3mm.It was suspected that foreign matter was in the 3.5x33mm xience xpedition.The contrast mix was a 1:1 ratio.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the device was returned for analysis.The reported deflation issues could not be confirmed due to the condition the device was returned for analysis.The reported foreign material present was not confirmed.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 similar incidents from this lot.It should be noted that the xience xpedition everolimus eluting coronary stent system instruction for use (ifu) lists device preparation prior to advancement to the lesion.Additionally, ifu states: deflate the balloon by pulling negative on the inflation device.Larger and longer balloons will take more time (up to 30 seconds) to deflate than smaller and shorted balloons.Confirm balloon deflation under fluoroscopy and wait 10-15 seconds longer.The investigation was unable to determine a conclusive cause for the reported deflation issues; however, factors that may contribute to deflation issues include, but are not limited to, manufacturing damage, contrast mixing, bent/kinked shaft while inside the anatomy affecting the deflation lumen and/or stretched outer member (om) and inner member (im) thereby reducing the deflation lumen.The reported suspected foreign material was not confirmed during return device analysis; therefore no conclusive cause can be determined.It should be noted the device was not prepped prior insertion into the anatomy against instructions for use and was only held negative for 10 seconds during deflation which is less than the recommended 30 seconds indicated for larger and longer balloons in the instructions for use.Additionally, damage to the inner and outer member was identified and the hypotube was found to be bent and kinked during return analysis likely due to operational context of the procedure, all of which may have contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION 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: 8591971
• MDR Text Key: 144455092
• Report Number: 2024168-2019-03661
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2022
• Device Catalogue Number: 1070350-33
• Device Lot Number: 8121941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR