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

Catalog Number	1125300-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2016
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 shaft kink was able to be confirmed.The reported stretched distal shaft was unable to be confirmed; however, the guide wire exit notch was torn.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a 3x38mm xience alpine rx stent delivery system (sds) was removed from the packaging, prepped and advanced toward the target lesion and the physician felt either a kinked or stretched distal shaft.No resistance was noted while removing the sds from the packaging.No resistance was noted while advancing into the patient anatomy.A same size alpine was used to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.Returned device analysis revealed that the distal shaft was torn at the guide wire exit notch extending distally for a length of 7.7 cm.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: 5992047
• Report Number: 2024168-2016-06583
• Device Sequence Number: 617433
• Product Code: NIQ
• UDI-Device Identifier: 08717648199394
• UDI-Public: (01)08717648199394(17)181108(10)5103041
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/30/2016

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: 11/08/2018
• Device Catalogue Number: 1125300-38
• Device Lot Number: 5103041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2016
• Initial Report FDA Received Date: 09/30/2016
• 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