MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1120400-15

Device Problems Material Rupture (1546); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

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 to treat a moderately tortuous, moderately calcified right coronary lesion.A 4x15mm xience alpine stent was advanced to the lesion and was inflated once at 9 atmospheres for deployment, but failed to inflate/deploy as leakage was noted coming from the balloon area as well as loss of pressure.A new xience stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported activation failure including expansion failures and material rupture 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 other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to activation failure including expansion failures (inflation issues) include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.Factors that may contribute to material ruptures include, but are not limited to, material damage, materials, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.There was no report of any damage noted to the stent delivery system (sds) during inspection or preparation of the device, which suggests that a product quality issue did not contribute to the reported complaint.In this case, it is possible that interaction between the device and the moderately tortuous, moderately calcified anatomy during advancement caused the noted bunched and kinked inner/outer member in addition to the torn shaft, thus causing the device to leak.Further manipulation of the device during retraction may have contributed to the noted stretched guide wire exit notch; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11837580
• MDR Text Key: 264326554
• Report Number: 2024168-2021-04121
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2023
• Device Catalogue Number: 1120400-15
• Device Lot Number: 0121241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1