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

Catalog Number 1120250-18

Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the patient presented experiencing an acute myocardial infarction and cardiogenic shock.The procedure was to treat a lesion in the ramus coronary artery.The xience alpine 2.50 x 18 mm stent delivery system was advanced to the lesion and deployed; however, it was observed that the stent was not there.A scan was performed and confirmed the stent was not in the patient anatomy.It was concluded that the stent was never on the delivery system.Another device was used to complete the procedure.There was no reported adverse patient effect or a clinically significant delay.No additional information was provided.

Manufacturer Narrative

Device codes: 2923 labeled.Internal file number (b)(4).Device codes 2017-labeled, 2306-labeled - removed.The device was returned for analysis.The reported stent dislodgement was confirmed.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 stent dislodgement.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: it was confirmed that the device was checked after removal of the protective sheath and the stent was noted on the device.The stent may have dislodged in the patient, but was noted to be removed after dislodging, as it reportedly does not remain in the patient.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 8348829
• MDR Text Key: 136609228
• Report Number: 2024168-2019-01201
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Catalogue Number: 1120250-18
• Device Lot Number: 8101141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 80