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	10/05/2017
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.Concomitant medical devices: guide wire: sion blue, guide catheter: hyperion.Evaluation summary: the device was returned for analysis.The reported bend/kink was able to be confirmed.The reported difficulty to remove was unable to be replicated in a testing environment as it was based on operational circumstances.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 as the sds was removed, resistance was met with the heavily tortuous, mildly calcified lesion resulting in the reported difficulty to remove.Manipulation of the device resulted in the reported/noted balloon bend/inner member kink.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 to treat a heavily tortuous, mildly calcified lesion in the proximal left anterior descending (lad) artery.The 2.25x28mm xience alpine stent was deployed; however, during attempted removal resistance was felt with the anatomy and the balloon bent.The stent delivery system (sds) was unable to be removed.A 1.2 mm balloon dilatation catheter (bdc) was inserted and advanced toward the alpine sds.The alpine sds was able to be pulled proximally with reaction force generated by pushing the bdc forward.The sds was removed from anatomy and the procedure was completed.There was no clinically significant delay in the procedure and no adverse patient effects.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: 6981454
• Report Number: 2024168-2017-08497
• Device Sequence Number: 444882
• Product Code: NIQ
• UDI-Device Identifier: 08717648199103
• UDI-Public: 08717648199103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: 02/22/2020
• Device Catalogue Number: 1125225-28
• Device Lot Number: 7021541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/26/2017
• 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