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

Catalog Number 1120350-15

Device Problems Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2018, the patient underwent a coronary procedure to treat a target lesion at the ostium of the proximal right coronary artery (rca).The stent delivery system was advanced to the lesion and per angiography, the balloon was noted to be inflated.It was felt that the stent was well apposed to the vessel wall.The balloon was deflated and it was noted that the stent was still on the balloon.The stent delivery system was removed from the patient anatomy, with the stent remaining on the balloon.Outside the patient anatomy, the device was inspected and the balloon showed signs of inflation.A second stent was used without difficulty to treat the target lesion.There was no reported adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

Event Description

Subsequent to the previously filed report, additional information was received that the stent delivery system (sds) was inflated to nominal pressure.The physician believes the stent was dislodged from the sds balloon before the sds entered the anatomy, but the stent remained proximal to the balloon on the sds catheter, which may be the reason the stent did not deploy.Prior to the physician manipulating the stent, the physician could see the stent was dislodged from the balloon.The balloon peeling/shredding was not noted by the physician, but was thought to have occurred during advancement through the complex patient anatomy, which included chronic total occlusion, thrombus and residual plaque.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis with balloon shredding at the proximal balloon shoulder.The reported stent dislodgement was confirmed.The reported failure to deploy (stent) could not be confirmed as the stent 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 xience alpine everolimus eluting coronary stent system (eecss), instructions for use states: prior to using the xience alpine eecss, 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.The ifu deviation does appear to have directly caused or contributed to the reported difficulties.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.A cine was received and reviewed by an abbott vascular clinical specialist, who concluded that the vessel appeared to be full of thrombus and residual plaquing which interfered with visualization throughout the entire intervention and there were multiple device exchanges.Based on the film review it could not be determined which device exchange or stent was in question or if there were any malfunctions regarding the referenced stent in this report.The balloon peeling/shredding was not noted by the physician, but was thought to have occurred during advancement through the complex patient anatomy, which included chronic total occlusion, thrombus and residual plaque.The reported failure to deploy appears to be related to circumstances of the procedure as it is likely the reported dislodgement prior to entering the anatomy likely caused the reported failure to deploy (stent) as the stent was not located on the balloon at the time of inflation.Additionally, it was reported that the device was believed to be damaged (dislodged) prior to use and was used in the patient's anatomy (against instructions for use).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 7616406
• MDR Text Key: 111854065
• Report Number: 2024168-2018-04642
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2021
• Device Catalogue Number: 1120350-15
• Device Lot Number: 8011041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1