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

Catalog Number 1500300-12

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other xience sierra and the xience pro stents referenced are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was performed to treat a lesion in the proximal right coronary artery.A 3.0 x 12 mm xience sierra stent, a 3.5 x 48 mm xience pro stent and a 4.0 x 18 mm xience sierra stent were implanted in the distal right coronary artery (rca) to proximal rca, in overlapping fashion.It was noted that the stents were under expanded and additional post dilatation was performed.After additional post dilatation was performed, all stents were noted to be well apposed to the vessel wall.There was no reported adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.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 difficult to deploy (wall apposition); however, the subsequent treatment appears to be related to the circumstances of the procedure.Based on the information reviewed, 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 SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8593526
• MDR Text Key: 144522152
• Report Number: 2024168-2019-03684
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Catalogue Number: 1500300-12
• Device Lot Number: 8021941
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: XIENCE SIERRA 4.0X18, XIENCE PRO: 3.5X48
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 66