MAUDE Adverse Event Report: AV-TEMECULA-CT MULTI-LINK RX VISION CORONARY STENT SYSTEM

Catalog Number	1007850-15
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/07/2016
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 missing component (stent) was confirmed as the stent was not returned; however, 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 reported missing component (protective sheath) was not returned.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 incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The investigation determined the reported difficulties appear to be related to operational context.
Event or Problem Description
It was reported during unpacking of the vision stent delivery system (sds) there was only the balloon and stylet, the protective sheath and stent were missing.The balloon had crimp marks between the markers as stent had been placed.There had been no resistance noted during removal of the sds from the hoop.The hoop was inspected for the protective sheath and stent but were not found.The sds was not used and a new vision sds was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MULTI-LINK RX VISION CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 5988860
• Report Number: 2024168-2016-06545
• Device Sequence Number: 66250
• Product Code: MAF
• UDI-Device Identifier: 08717648050787
• UDI-Public: (01)08717648050787(17)181031(10)5111641
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• 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): 09/29/2016

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: 10/31/2018
• Device Catalogue Number: 1007850-15
• Device Lot Number: 5111641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2016
• Initial Report FDA Received Date: 09/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1