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

Model Number 1550250-33

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a none tortuous, mildly calcified mid-right coronary artery that was 80% stenosed.The 2.50x33mm xience sierra balloon would not inflate.Eventually, the balloon partially inflated.The stent was post-dilated with an unspecified balloon and it remains in the lesion.It was then noted there was a leak from a pinhole in the shaft.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported shaft torn material, leak and inflation problems were 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 was unable to determine a conclusive cause for the reported shaft tear.The reported leak and inflation issues appear to be related to circumstances of the procedure as it is likely the inner member damage caused the leak and subsequent inflation issues (failure to inflate and irregular inflation).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: 9833119
• MDR Text Key: 186126592
• Report Number: 2024168-2020-02442
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227134
• UDI-Public: 08717648227134
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

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: 07/28/2020
• Device Model Number: 1550250-33
• Device Catalogue Number: 1550250-33
• Device Lot Number: 9071841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/14/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR