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

Catalog Number 1078250-48

Device Problems Inflation Problem (1310); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.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 performed to treat a concentric and de novo lesion in the mid and proximal left anterior descending artery with no tortuosity and no calcification that was 90% stenosed.Subsequent to pre-dilatation, intravascular ultrasound (ivus) was performed and concentric plaque with no calcification was observed.A 2.5 x 48 mm xience xpedition stent delivery system (sds) was advanced to the target lesion and was inflated at 12 atmospheres, but the sds did not inflate.Another attempt was made to inflate the sds again to 12 atmospheres, but angiography confirmed the sds still did not inflate.The sds was removed, and it was observed that the stent was not on the balloon.The stent was found half-stretched, inside the protective sheath and stylet.The procedure was successfully completed with another 2.5 x 48 mm xience xpedition sds.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported stent dislodgement and material deformation were confirmed.The reported inflation issues were 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.The xience xpedition everolimus eluting coronary stent system instructions for use (ifu) states: prior to using the xience xpedition everolimus eluting coronary stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.In this case, it does not appear the instruction for use (ifu) deviation related to failure to follow instructions contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported stent dislodgement; however, the reported material deformation appears to be related to circumstances of the procedure as it is likely the stent was damaged due to the reported dislodgement during sheath removal.The investigation was unable to determine a conclusive cause for the reported inflation issues as no issue was identified during return device analysis.Additionally, the reported stent dislodgement was not identified until after the device was inserted into the patients anatomy indicating visual inspection of the device was not performed prior to use (against instructions for use).There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual, dimensional and functional inspection was performed on the returned device.The reported stent dislodgement and material deformation were confirmed.The reported inflation issue was not confirmed.The xience xpedition everolimus eluting coronary stent system (eecss), instructions for use (ifu, states: prior to using the xience xpedition, xience xpedition sv, and xience xpedition ll everolimus eluting coronary stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.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 did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported stent dislodgement and inflation issue.The reported material deformation appears 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 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: 7726398
• MDR Text Key: 115391868
• Report Number: 2024168-2018-05819
• 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,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2021
• Device Catalogue Number: 1078250-48
• Device Lot Number: 8051741
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 08/07/2018; 08/23/2018
• Supplement Dates FDA Received: 08/10/2018; 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR