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

Catalog Number	1125400-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2017
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.Evaluation summary: the device was returned for analysis.The reported difficulty to deploy and the reported inflation issue were unable to be confirmed.A conclusive cause for the reported difficulties cannot be determined.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
The procedure was to treat a 90 percent stenosed, moderately tortuous, and heavily calcified concentric de novo lesion in the distal right coronary artery.Following pre-dilatation with a 2.0x20mm non-abbott balloon, thrombus aspiration was performed due to thrombus enter the peripheral vessel.A 4.0x28mm xience alpine stent was implanted at the lesion site at 10 atmospheres for 20 seconds twice; however, the distal part of the stent didn't look fully expanded.An intravascular ultrasound catheter measured the distal part of the stent at 2.5mm.The stent delivery catheter was re-advanced and additional dilatation was performed.The distal part of the stent was expanded to match the rest of the stent and the procedure was successfully completed.After the procedure an attempt to inflate the balloon of the delivery catheter was made; however, the distal part of the balloon would not fully expand.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: 6425589
• Report Number: 2024168-2017-02408
• Device Sequence Number: 943139
• Product Code: NIQ
• UDI-Device Identifier: 08717648199646
• UDI-Public: (01)08717648199646(17)180604(10)5060241
• 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): 03/22/2017

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: 06/04/2018
• Device Catalogue Number: 1125400-28
• Device Lot Number: 5060241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: SION BLUEGUIDE CATHETER: HYPERION AL
• Outcome Attributed to Adverse Event: Required Intervention