MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070350-48

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problems Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 03/06/2019

Event Type  Death  

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 additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately tortuous and moderately calcified proximal right coronary artery.A 3.5 x 48 mm xience xpedition stent was implanted in the lesion.However, it was not possible to deflate the stent delivery balloon, and there was difficulty in removing the device.The distal shaft then became separated; the patient became unwell and was taken to coronary artery bypass graft (cabg) surgery.The distal shaft was removed; however, the patient expired from right vessel myocardial infarction and shock.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Added conclusion code - 23.The reported physical resistance and difficulty to remove were unable to be replicated in a testing environment as it was based on operational circumstances.

Event Description

Subsequent to the supplemental report, a correction was made.The 3.5 x 48 mm xience xpedition stent delivery system was not properly deflated as it was only deflated for 7 - 8 seconds instead of 30 seconds.No additional information was provided.

Manufacturer Narrative

Device codes: 2017 labeled.B)(4).Conclusion codes 23 and 67 were removed.Device code 2017 - failure to follow steps.Evaluation summary: the device was returned for analysis.The reported deflation issue and detachment of a device component (tip) were confirmed.The reported physical resistance and difficulty to remove were unable to be replicated in a testing environment as they were based on operational circumstances.It was reported that negative pressure was held for 7-8 seconds to try to deflate the balloon prior to the attempted removal of the stent delivery balloon with the balloon still in inflated conditions.It should be noted that the instruction for use (ifu) eecss, xience xpedition 48, ce 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 shorter balloons.Confirm balloon deflation under fluoroscopy and wait 10 - 15 seconds longer.Position the inflation device to "negative" or "neutral" pressure.Stabilize guide catheter position just outside coronary ostium and anchor in place.Maintain guide wire placement across stent segment.Gently remove the stent delivery system with slow and steady pressure.Tighten the rotating hemostatic valve.In this case, it might be possible that the balloon would had deflated if given more time.A review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported deflation issues appear to be related to procedural circumstances.Based on the information reviewed and returned device analysis, it is likely the resistance met during advancement from the guiding catheter was due to an interaction with the patient anatomy causing the inner/outer member deformation which may have resulted in deflation issues.The force was applied during retraction of the device with inflated balloon while the balloon required additional time to deflate, stretched the inner and outer member materials.This further caused the reported difficult to deflate and subsequently caused material separation.There is no indication of a product quality issue with respect to the manufacture, labeling or design of the returned device.

Manufacturer Narrative

(b)(4).Correction: conclusion code 67 removed.Additional analysis of the returned device identified a pin hole in the balloon proximal to the distal balloon marker.Testing performed to determine the root cause of the pinhole identified a longitudinal scratch in the balloon distal to the pinhole.This is likely due to external interaction with the patient anatomy or guiding catheter.As negative pressure was applied with the proxy indeflator, fluid would not fully deflate from the balloon confirming the reported deflation issue.

Manufacturer Narrative

Device codes: 2920 not labeled.(b)(4).Evaluation summary: the device was returned for analysis.The reported deflation issue and detachment of a device component (tip) were confirmed.A review of the complaint history did not indicate a lot specific quality issue.A cine was received and reviewed by an abbott vascular clinical specialist and the reviewer concluded from the information provided the sds could be delivered and deployed but could not be deflated.In attempting to remove the sds a shaft separation occurred.Patient was taken for emergent cabg and expired that same day.Death in this case is due to the catheter separation with retained shaft component that required surgical intervention to remove.The reported patient effects of death and myocardial infarction are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation determined the reported deflation issues appear to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

Event Description

Subsequent to the initial india report, additional information was received.A 2.0 x 8 mm nc trek balloon catheter and a 2.5 x 33 mm xience xpedition stent delivery system (sds) were used as well and did not have any device issues.It was reported that neither device caused or contributed to the patient death.The 3.5 x 48 mm xience xpedition stent delivery system met resistance with the anatomy during advancement and was inflated once at 14 atmospheres.The patient expired on (b)(6) 2019, and it was reported that the 3.5 x 48 mm xience xpedition sds was the only device to have caused the death.No additional information was provided.

• Brand Name: XIENCE XPEDITION 48 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: 8466907
• MDR Text Key: 140418919
• Report Number: 2024168-2019-02448
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/16/2019

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: 11/15/2021
• Device Catalogue Number: 1070350-48
• Device Lot Number: 8111241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 07/13/2019; 08/08/2019; 09/26/2019; 10/03/2019
• Supplement Dates FDA Received: 08/08/2019; 08/27/2019; 09/26/2019; 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death