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

Catalog Number 1120250-15

Device Problems Kinked (1339); Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

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.Concomitant medical products: guide wire: rountroungh 0.014, guide cath: vl 3.5, sheath: 6 french.The device 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the device interacted with the guiding wire and/or guiding catheter during advancement causing the reported physical resistance and subsequent kinked shaft and device operating differently than expected (support).The device felt resistance during removal, likely interacting with the guide wire and/or guiding catheter, causing the reported difficulty to remove.There is no indication of a product quality issue with respect to design, manufacture or labeling.

Event Description

It was reported that the procedure was to treat a 90% stenosed lesion in the first diagonal artery.Resistance advancing a 2.5x15mm xience alpine stent delivery system (sds) was felt with an unknown device.The stent was deployed successfully; however, resistance with an unknown device was felt when removing the sds.Additionally, the shaft of the sds was kinked.A decrease in navigability was noted.The procedure ended well, with good angiographic results and coronary flow timi iii.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Event Description

Additional information: return device analysis revealed that the dispenser coil and the shaft was kinked (consistent with one another).Follow-up with the account confirmed that the dispenser coil and shaft were noted to be kinked prior to use.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: it was initially reported that the device would not be returning for analysis.However, device was returned for evaluation.(b)(4).Evaluation summary: the device was returned for analysis.The reported kinked shaft and kinked dispenser coil were confirmed.The reported support issue, difficulty to position and difficulty to remove could not be tested due to the condition the device was returned for analysis.The xience alpine everolimus eluting coronary stent system instructions for use (ifu) states: prior to using the xience alpine everolimus eluting coronary stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Do not use if any defects are noted.In this case, it does appear the ifu deviation contributed to the reported device issues.The investigation was unable to determine a conclusive cause for the reported kinked dispenser; however, it appears the reported shaft kink is due to operational context as it is likely the kinked dispenser coil caused the reported shaft kinks.Additionally, all other reported difficulties appear to be related to operational context of the procedure as it appears the device was used kinked (against instructions for use) which likely resulted in interaction with the guiding wire and/or guiding catheter during advancement and retraction causing the reported difficulty to position, device operating differently than expected (support issues), and difficulty to remove.

• Brand Name: XIENCE ALPINE 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: 7538247
• MDR Text Key: 109113969
• Report Number: 2024168-2018-03866
• 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
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2020
• Device Catalogue Number: 1120250-15
• Device Lot Number: 7080841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 60