MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1550250-15

Device Problem Inflation Problem (1310)

Patient Problems Air Embolism (1697); No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual and functional inspections were performed on the returned device.The reported inflation issue was 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 similar incidents from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a lesion in the left anterior descending artery.A 2.5x15mm xience sierra stent delivery system (sds) was advanced without issues; however, completely failed to inflate.The sds was removed without issues and the procedure was successfully completed with a new 2.5x15mm xience sierra sds.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Patient codes: 1697 labeled.Internal file number - (b)(4).Corrections: conclusion code 4307 was removed.Patient code 2199 was removed.Evaluation summary: the reported patient effect of air emoblism is listed in the sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported inflation issue appears to be related to operational context as it was noted during return analysis that the inner and outer member were stretched and torn distally from the guide wire exit notch.The tearing of the guide wire exit notch appears to have resulted from an interaction with the guide wire.This type of mechanical damage can occur if an attempt is made to pull the catheter in an opposite direction as the guide wire.In this case, it is likely the devices were manipulated during advancement, resulting in the noted tear and subsequently the reported inflation issue.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the previously filed report, additional information was received: due to failure to inflate a mixture of contrast and air went into the patient and the patient experienced no re-flow.The patient was treated with interchange nitro and interchange nipride.The patient is doing well.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8375955
• MDR Text Key: 137371571
• Report Number: 2024168-2019-01534
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227097
• UDI-Public: 08717648227097
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2019
• Device Catalogue Number: 1550250-15
• Device Lot Number: 8091841
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2019
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention