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

Catalog Number 1500350-15

Device Problems Inflation Problem (1310); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

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 exemption number (b(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

Event Description

It was reported that the procedure was performed to treat an unspecified lesion.A 3.50x15mm xience sierra stent delivery system (sds) was advanced and during inflation the balloon would not inflate as contrast leaked from the inflation port of the hub that was connected to the indeflator.The stent was not implanted.A new unspecified stent was used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported inflation issue was confirmed through observation and the reported loose connection could not be 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 investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device experienced inflation issues due to the noted crack in the hub.The reported loose connection was not confirmed; however, it is likely the leak due to the crack was identified as a loose connection.The cause of the cracked hub cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001.

Event Description

It was reported that the procedure was performed to treat an unspecified lesion.A 3.50x15mm xience sierra stent delivery system (sds) was advanced and during inflation, the balloon would not inflate as contrast leaked from the inflation port of the hub that was connected to the indeflator.The stent was not implanted.A new unspecified stent was used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.On 8/5/2019 additional information received: the inflation device used during the procedure was a non-abbott device.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8802700
• MDR Text Key: 151442065
• Report Number: 2024168-2019-10133
• 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
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2021
• Device Catalogue Number: 1500350-15
• Device Lot Number: 8082041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1