MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1012462-28

Device Problems Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944); Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Though the device is not approved for sale in the u.S., it uses a delivery system which is similar to a device sold in the u.S.The device is expected to be returned for evaluation.It has not yet been received.A follow-up will be submitted with all relevant information.

Event Description

It was reported that during unpackaging of a 2.5x28mm implant delivery catheter, when the protective sheath was removed from the catheter there was resistance and the distal balloon shaft was noted to not be smooth.There was a glue like substance on the distal shaft surface close to the connection portion.There was a very big profile at the distal edge of the implant and some folds at the balloon shaft.The device was not used in the patient.A new 2.5x28mm implant delivery system was opened which was normal and implanted successful.There was no clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported break and irregular texture was confirmed.The reported difficulty removing the protective sheath was not tested as the sheath was not returned.The reported glue on the shaft was not confirmed.Based on visual and dimensional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined the reported break and irregular texture appear to be related to circumstances of the procedure; however a conclusive cause for the reported difficulty removing the protective sheath and glue on the shaft could not be determined.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no 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 Description

Subsequent to the initial mdr being filed the following information was provided: the device was returned with the balloon separated from the outer member at the proximal balloon seal.Follow-up with the site clarified that the separation occurred during attempted removal of the protective sheath.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5321782
• MDR Text Key: 34884309
• Report Number: 2024168-2015-07786
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2016
• Device Catalogue Number: 1012462-28
• Device Lot Number: 5033161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1