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

Catalog Number	1125225-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported missing component/stent was able to be confirmed.As there were crimp marks on the balloon between the markers, suggesting the stent was originally positioned correctly and securely at the time of manufacture, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during sheath removal/during preparation of use and/or inadvertent device inflation resulted in dislodging the stent from the balloon.It should be noted that the xience alpine eluting coronary stent system instructions for use states: prior to using the xience alpine stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the left anterior descending (lad) artery with no calcification.The 2.25 x 28 mm xience alpine stent delivery system (sds) was advanced to the lesion; however, the stent was unable to be located under fluoroscopy.Additional evaluation was performed under fluoro and it was confirmed that the stent was not inside the anatomy.The guiding catheter was removed and flushed with saline but the stent was not in the guiding catheter.It was reported that stent was not found in the protective sheath either.It was stated that there was never a stent implant on the balloon.The procedure was successfully completed after two unspecified stents were implanted.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the previously filed medwatch report, a user facility medwatch was received stating: while attempting to insert a drug eluding cardiac stent, after inserting the delivery catheter and inflating the balloon, there was no stent visualized on the balloon.The procedure was repeated with another stent.This time the delivery catheter was inserted.The balloon and stent deployed as usual.There was no harm to the patient.What was the original intended procedure? insertion of drug eluding stent.

• 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: 6349566
• Report Number: 2024168-2017-01423
• Device Sequence Number: 13713621
• Product Code: NIQ
• UDI-Device Identifier: 08717648199103
• UDI-Public: (01)08717648199103(17)190911(10)6090641
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2019
• Device Catalogue Number: 1125225-28
• Device Lot Number: 6090641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 120