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

Catalog Number 1500300-15

Device Problems Material Rupture (1546); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow-up will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat an unknown coronary artery.During the first inflation of the balloon of the 3.00x15 mm xience sierra stent, it was not possible to reach nominal pressure, and the balloon was leaking when attempting to deploy the stent.The stent was partially deployed.The sds was removed and another balloon was used to completely deploy the stent.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-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.The device was returned for analysis.The reported material rupture was confirmed.The reported difficulty to activate (deploy) was confirmed through observation.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 from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the anatomy and/or guiding catheter during advancement to the lesion causing the reported material rupture (pinhole) and subsequent difficulty to deploy.It should be noted, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8899352
• MDR Text Key: 154536627
• Report Number: 2024168-2019-10898
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2022
• Device Catalogue Number: 1500300-15
• Device Lot Number: 9041041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention