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

Catalog Number 1500300-12

Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

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 the procedure was to treat an unspecified artery.The inflation syringe could not fit to the catheter luer connection of a 3.0 x 12 mm xience sierra stent delivery system (sds) as the screw at the connector seems to be defective.Another xience sierra sds was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis revealed that fluid leaked out of the noted cracks at the proximal end of the hub of the sds.Additionally, the sds was returned with blood in the balloon folds and on the balloon.Additional reported information indicates that cracks and leak were noted at the hub as the physician could not fit the syringe.No additional information was provided.

Manufacturer Narrative

A visual and functional inspections were performed on the returned sds.The reported hub cracks and leak was confirmed.The reported connection issues were unable to be confirmed since the device was able to securely connection with the proxy syringe and inflation device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot or relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot or relabeled lot.The investigation was unable to determine a conclusive cause for the reported connection issues, hub cracks resulting in hub leaks.It is possible that during connection of the syringe to the hub during device prep, the syringe connection port was over torqued causing the hub to crack resulting in the reported connection issues and leak; however, this could not be confirmed.The noted bends on the hypotube likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE SIERRA 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: 10987974
• MDR Text Key: 220961982
• Report Number: 2024168-2020-10402
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Catalogue Number: 1500300-12
• Device Lot Number: 9031441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1