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

Catalog Number 1500300-23

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Intimal Dissection (1333); Cardiac Enzyme Elevation (1838); Occlusion (1984)

Event Date 01/09/2019

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.

Event Description

It was reported that on (b)(6) 2019, pre-dilatation was performed in the mid left anterior descending (lad) coronary artery lesion.A 3.0x23mm xience sierra stent was implanted in the mid lad.Following, stent underexpansion and a proximal stent dissection were noted.As treatment, post-dilatation was performed and a 4.0x18mm xience sierra stent was implanted.Acceptable procedure results were reported.Post procedure, elevated troponin was observed.An electrocardiogram was performed.There was no reported myocardial infarction.Reportedly, the troponin elevation was due to a loss of the diagonal branch related to the 3.0x23mm xience sierra stent underexpansion.Per physician, the troponin elevation was not serious and required no further treatment.No additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number - (b)(4).If follow-up, what type correction: mfr site- manufacturer contact office-name/address.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 difficulty to deploy and subsequent patient effects; however, factors that may contribute difficulty to deploy (wall apposition) include but are not limited to incorrect device size for lesion, patient anatomical morphology, and patient disease state.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8776267
• MDR Text Key: 150567895
• Report Number: 2024168-2019-05501
• 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: foreign,health professional,s
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Catalogue Number: 1500300-23
• Device Lot Number: 808164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATH: 5FR; GUIDE CATH: 5FR
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 86