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

Catalog Number	1125250-33
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2017
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.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 other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the reported difficulty to position was a result of the sds not being coaxially aligned, such that as the sds was being advanced it interacted with the guideliner causing resistance.Interaction with the guideliner and/or manipulation of the device resulted in the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 2.5 x 23 mm xience alpine sds referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mildly tortuous, moderately calcified, 70% stenosed, left anterior descending (lad) coronary artery and a lesion in the mildly tortuous, non-calcified, 70% stenosed, diagonal coronary artery utilizing the kissing stent method.A 2.50 x 23 mm xience alpine stent delivery system (sds) was selected to treat the lesion in the lad.The sds was advanced to the lesion, positioned, although it was not deployed at that time.A 2.5 x 33 mm xience alpine sds was selected to treat the lesion in the diagonal coronary artery.The sds was advanced toward the lesion, met resistance with the guiding catheter and would not negotiate the curve into the diagonal.During removal of the sds from the anatomy, the stent dislodged from the balloon and was found inside the guiding catheter.It was decided to go ahead and deploy the first stent in the lad.When they went to reposition the stent prior to deployment it was observed under fluoroscopy that the balloon and stent were not moving as the delivery system was moved.It was determined that the balloon and stent had separated from the delivery system.The sds was removed from the anatomy.No attempt was made to retrieve the separated balloon and stent.Unspecified stents were then successfully implanted in the proximal lad, distal left main, and mid circumflex.A surgical consult was done and it was determined that the patient was not a good candidate for surgical removal of the balloon and stent from the lad.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: 6927452
• Report Number: 2024168-2017-08036
• Device Sequence Number: 19029549
• Product Code: NIQ
• UDI-Device Identifier: 08717648199202
• UDI-Public: 08717648199202
• 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
• Report Date (Section B): 10/06/2017

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: 06/21/2020
• Device Catalogue Number: 1125250-33
• Device Lot Number: 7061441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR