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

Catalog Number	1125325-23
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual inspections were performed on the returned device.The reported dislodgement was confirmed.The reported physical resistance and difficulty to remove could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported dislodgement, physical resistance, difficulty to remove and subsequent patient effect of foreign body in patient appear to be related to challenging anatomical conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was performed to treat a lesion with heavy calcification and heavy tortuosity in the proximal circumflex and proximal left anterior descending coronary artery.The 3.25 x 23 mm xience alpine stent delivery system (sds) was advanced with resistance and became stuck in the ostial circumflex/left main artery.The sds was withdrawn, but the stent remained lodged in calcium.A small balloon catheter was advanced up to the dislodged stent and the balloon was put through the dislodged stent and was able to remove the dislodged stent from the calcification.However, when the sds was being retrieved the stent became lost in the left main.Fluoroscopy could not locate the dislodged stent.It was uncertain if the dislodged stent remained free floating in the patient anatomy.The procedure was aborted due to the heavily calcified vessel.The patient remained stable during and after the procedure.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8636403
• Report Number: 2024168-2019-04046
• Device Sequence Number: 1992134
• Product Code: NIQ
• UDI-Device Identifier: 08717648199455
• UDI-Public: 08717648199455
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2021
• Device Catalogue Number: 1125325-23
• Device Lot Number: 8032641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR